Effects of Low-Carbohydrate and Low-Fat Diets: A Randomized Trial
Open accessAbstract
BACKGROUND: Low-carbohydrate diets are popular for weight loss, but their cardiovascular effects have not been well-studied, particularly in diverse populations. OBJECTIVE: To examine the effects of a low-carbohydrate diet compared with a low-fat diet on body weight and cardiovascular risk factors. DESIGN: A randomized, parallel-group trial. (ClinicalTrials.gov: NCT00609271). SETTING: A large academic medical center. PARTICIPANTS: 148 men and women without clinical cardiovascular disease and diabetes. INTERVENTION: A low-carbohydrate (<40 g/d) or low-fat (<30% of daily energy intake from total fat [<7% saturated fat]) diet. Both groups received dietary counseling at regular intervals throughout the trial. MEASUREMENTS: Data on weight, cardiovascular risk factors, and dietary composition were collected at 0, 3, 6, and 12 months. RESULTS: Sixty participants (82%) in the low-fat group and 59 (79%) in the low-carbohydrate group completed the intervention. At 12 months, participants on the low-carbohydrate diet had greater decreases in weight (mean difference in change, -3.5 kg [95% CI, -5.6 to -1.4 kg]; P = 0.002), fat mass (mean difference in change, -1.5% [CI, -2.6% to -0.4%]; P = 0.011), ratio of total-high-density lipoprotein (HDL) cholesterol (mean difference in change, -0.44 [CI, -0.71 to -0.16]; P = 0.002), and triglyceride level (mean difference in change, -0.16 mmol/L [-14.1 mg/dL] [CI, -0.31 to -0.01 mmol/L {-27.4 to -0.8 mg/dL}]; P = 0.038) and greater increases in HDL cholesterol level (mean difference in change, 0.18 mmol/L [7.0 mg/dL] [CI, 0.08 to 0.28 mmol/L {3.0 to 11.0 mg/dL}]; P < 0.001) than those on the low-fat diet. LIMITATION: Lack of clinical cardiovascular disease end points. CONCLUSION: The low-carbohydrate diet was more effective for weight loss and cardiovascular risk factor reduction than the low-fat diet. Restricting carbohydrate may be an option for persons seeking to lose weight and reduce cardiovascular risk factors. PRIMARY FUNDING SOURCE: National Institutes of Health.
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- Findingown data
Physical activity levels were similar throughout the study.
“Physical activity levels were similar throughout the study.”
Quote in the paperNot a substantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Findingown data
LDL cholesterol reductions did not differ significantly between the low-carbohydrate and low-fat groups.
“Our study also found reductions in LDL cholesterol level among participants in both groups, with no significant difference between the groups.”
Quote in the paperSubstantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Findingown data
At 12 months, the low-carbohydrate group had a greater increase in lean mass (mean difference in change, 1.7% [CI, 0.6% to 2.8%]; P = 0.003).
“significantly greater proportional increases in lean mass (mean difference in change at 12 months, 1.7% [CI, 0.6% to 2.8%]; P = 0.003)”
Quote in the paperSubstantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Findingown data
At 12 months, the low-carbohydrate group had a greater decrease in the ratio of total to HDL cholesterol (mean difference in change, −0.44 [CI, −0.71 to −0.16]; P = 0.002).
“ratio of total to high-density lipoprotein (HDL) cholesterol (mean difference in change, −0.44 [CI, −0.71 to −0.16]; P = 0.002)”
- Also stated in: § Serum Lipid Levels · plain
“Ratios of total to HDL cholesterol decreased significantly only among participants in the low-carbohydrate group, and the decreases were significantly greater than those in the low-fat group (mean difference in change at 12 months, −0.44 [CI, −0.71 to −0.16]; P = 0.002).”
Quote in the paperSubstantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Also stated in: § Serum Lipid Levels · plain
- Findingown data
Plasma glucose levels did not significantly change in either group.
“Plasma glucose levels also did not significantly change in either group.”
Quote in the paperNot a substantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Findingown data
At 12 months, the low-carbohydrate group had a greater reduction in fat mass (mean difference in change, −1.5% [CI, −2.6% to −0.4%]; P = 0.011).
“fat mass (mean difference in change, −1.5% [CI, −2.6% to −0.4%]; P = 0.011)”
- Also stated in: § Body Weight and Composition and Waist Circumference · plain
“those on the low-carbohydrate diet had significantly greater proportional reductions in fat mass (mean difference in change at 12 months, −1.5% [CI, −2.6% to −0.4%]; P = 0.011)”
Quote in the paperSubstantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Also stated in: § Body Weight and Composition and Waist Circumference · plain
- Findingown data
At 12 months, the low-carbohydrate group had a greater decrease in triglyceride level (mean difference in change, −0.16 mmol/L [−14.1 mg/dL] [CI, −0.31 to −0.01 mmol/L {−27.4 to −0.8 mg/dL}]; P = 0.038).
“triglyceride level (mean difference in change, −0.16 mmol/L [−14.1 mg/dL] [CI, −0.31 to −0.01 mmol/L {−27.4 to −0.8 mg/dL}]; P = 0.038)”
- Also stated in: § Serum Lipid Levels · plain
“Serum levels of triglycerides also decreased significantly in both groups, with greater decreases among participants in the low-carbohydrate group (mean difference in change at 12 months, −0.16 mmol/L [−14.1 mg/dL] [CI, −0.31 to −0.01 mmol/L {−27.4 to −0.8 mg/dL}]; P = 0.038)”
Quote in the paperSubstantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Also stated in: § Serum Lipid Levels · plain
- Findingown data
Systolic and diastolic blood pressures did not significantly decrease in either group at 12 months.
“Systolic and diastolic blood pressures did not significantly decrease among participants in either group, and mean differences in change between the groups were also not significant at 12 months.”
Quote in the paperNot a substantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Findingown data
At 12 months, the low-carbohydrate group had a greater decrease in CRP level (mean difference in change, −15.2 nmol/L [CI, −27.6 to −1.9 nmol/L]; P = 0.024).
“participants in the low-carbohydrate group had significantly greater decreases in CRP level than those in the low-fat group (mean difference in change at 12 months, −15.2 nmol/L [CI, −27.6 to −1.9 nmol/L]; P = 0.024)”
Quote in the paperSubstantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Findingown data
At 12 months, the low-carbohydrate group had a greater increase in HDL cholesterol level (mean difference in change, 0.18 mmol/L [7.0 mg/dL] [CI, 0.08 to 0.28 mmol/L {3.0 to 11.0 mg/dL}]; P < 0.001).
“greater increases in HDL cholesterol level (mean difference in change, 0.18 mmol/L [7.0 mg/dL] [CI, 0.08 to 0.28 mmol/L {3.0 to 11.0 mg/dL}]; P< 0.001)”
- Also stated in: § Serum Lipid Levels · plain
“High-density lipoprotein cholesterol level increased significantly more in the low-carbohydrate group than in the low-fat group (mean difference in change at 12 months, 0.18 mmol/L [7.0 mg/dL] [CI, 0.08 to 0.28 mmol/L {3.0 to 11.0 mg/dL}]; P < 0.001).”
Quote in the paperSubstantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Also stated in: § Serum Lipid Levels · plain
- Findingown data
Waist circumference decreased significantly in both groups.
“Participants in both groups significantly reduced their waist circumference.”
Quote in the paperNot a substantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Findingown data
The proportion of participants with detectable urinary ketone levels was significantly higher in the low-carbohydrate group than in the low-fat group at 3, 6, and 12 months.
“The proportion of participants with detectable urinary ketone levels was significantly higher in the low-carbohydrate group than in the low-fat group at 3, 6, and 12 months (data not shown).”
Quote in the paperNot a substantial claim - Findingown data
No serious adverse events were reported during the study.
“No serious adverse events were reported during the course of the study.”
Quote in the paperNot a substantial claim - Findingown data
Total and LDL cholesterol levels did not significantly change in either group at 12 months.
“At 12 months, serum levels of total and LDL cholesterol had not significantly changed among participants in either group.”
Quote in the paperNot a substantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Findingown data
At 12 months, the low-carbohydrate group lost more weight than the low-fat group (mean difference in change, −3.5 kg [95% CI, −5.6 to −1.4 kg]; P < 0.001).
“At 12 months, participants on the low-carbohydrate diet had greater decreases in weight (mean difference in change, −3.5 kg [95% CI, −5.6 to −1.4 kg]; P < 0.001)”
- Also stated in: § Body Weight and Composition and Waist Circumference · plain
“The reduction in body weight was significantly greater in the low-carbohydrate group (mean difference in change at 12 months, −3.5 kg [95% CI, −5.6 to −1.4 kg]; P = 0.002).”
Quote in the paperSubstantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Also stated in: § Body Weight and Composition and Waist Circumference · plain
- Findingown data
Participants in the low-carbohydrate group achieved an average of 30% of daily energy from carbohydrate over 12 months.
“Over the course of 12 months, participants in the low-carbohydrate group in our study achieved an average of 30% of daily energy from carbohydrate.”
Quote in the paperNot a substantial claim- Rests on an assumption: Self-reported 24-hour dietary recalls accurately reflect participants' actual dietary intake.
- Findingown data
In sensitivity analysis, the low-carbohydrate group lost significantly more weight than the low-fat group (mean difference in change at 12 months, −3.6 kg [CI, −5.7 to −1.4 kg]; P = 0.001).
“Specifically, participants in the low-carbohydrate group lost significantly more weight than those in the low-fat group (mean difference in change at 12 months, −3.6 kg [CI, −5.7 to −1.4 kg]; P = 0.001).”
Quote in the paperNot a substantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Findingown data
Total energy intake was similar between groups during follow-up.
“During the follow-up period, total energy intake was similar between groups.”
Quote in the paperNot a substantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Findingown data
The overall level of risk in the sample was low (about 4% over 10 years at baseline).
“however, the overall level of risk was low in our sample (about 4% over 10 years at baseline).”
Quote in the paperSubstantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Findingown data
At 12 months, the low-carbohydrate group had a greater decrease in estimated 10-year Framingham CHD risk (mean difference in change, −1.4% [CI, −2.1% to −0.6%]; P < 0.001).
“The reductions in estimated 10-year risk for CHD were significantly greater in the low-carbohydrate group at 12 months (mean difference in change, −1.4% [CI, −2.1% to −0.6%]; P < 0.001).”
Quote in the paperSubstantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Findingown data
Between-group differences in blood pressure change were not significant at 12 months.
“Systolic and diastolic blood pressures did not significantly decrease among participants in either group, and mean differences in change between the groups were also not significant at 12 months.”
Quote in the paperNot a substantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Premisecitation
Few randomized controlled trials have studied carbohydrate restriction's effects on cardiovascular risk factors in a diverse population with many black persons.
“Few randomized, controlled trials thus far have examined the effects of carbohydrate restriction on CVD risk factors in a diverse population with a significant proportion of black persons.”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [4] Stern L Iqbal N Seshadri P Chicano KL Daily DA McGrory J The effects of low-carbohydrate versus conventional weight loss diets in severely obese adults: one-year follow-up of a randomized trial Ann Intern Med 2004 140 778 85 15148064 source
Not checked in the free run.
- cites [5] Davis NJ Tomuta N Schechter C Isasi CR Segal-Isaacson CJ Stein D Comparative study of the effects of a 1-year dietary intervention of a low-carbohydrate diet versus a low-fat diet on weight and glycemic control in type 2 diabetes Diabetes Care 2009 32 1147 52 10.2337/dc08-2108 19366978 PMC2699720 source
Not checked in the free run.
- cites [6] Sacks FM Bray GA Carey VJ Smith SR Ryan DH Anton SD Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates N Engl J Med 2009 360 859 73 10.1056/NEJMoa0804748 19246357 PMC2763382 source
Not checked in the free run.
- Study design and conductcitation
The study had high rates of dietary adherence, as shown by 24-hour recall and urinary ketone levels.
“In addition, this study had high rates of dietary adherence, as shown by 24-hour recall and urinary ketone levels (31).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [31] Larosa JC Fry AG Muesing R Rosing DR Effects of high-protein, low-carbohydrate dieting on plasma lipoproteins and body weight J Am Diet Assoc 1980 77 264 70 7410754
Not checked in the free run.
- Rests on an assumption: Self-reported 24-hour dietary recalls accurately reflect participants' actual dietary intake.
- Interpretationreasoning
The clinical significance of the difference in 10-year CHD risk score is not clear.
“Thus, the clinical significance of this difference is not clear.”
Quote in the paperSubstantial claim - Interpretationown data
Loss of fat mass accounts for most of the reduction in body weight on a low-carbohydrate diet.
“In addition, our findings suggest that the loss of fat mass accounts for most of the reduction in body weight on a low-carbohydrate diet, which is consistent with other study findings (19, 21).”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [19] Brinkworth GD Noakes M Buckley JD Keogh JB Clifton PM Long-term effects of a very-low-carbohydrate weight loss diet compared with an isocaloric low-fat diet after 12 mo Am J Clin Nutr 2009 90 23 32 10.3945/ajcn.2008.27326 19439458 source
Not checked in the free run.
- cites [21] Foster GD Wyatt HR Hill JO Makris AP Rosenbaum DL Brill C Weight and metabolic outcomes after 2 years on a low-carbohydrate versus low-fat diet: a randomized trial Ann Intern Med 2010 153 147 57 10.7326/0003-4819-153-3-201008030-00005 20679559 PMC2949959 source
Not checked in the free run.
- The authors state this as an assumption: Missing outcome data are missing at random.
- Interpretationown data
Conclusions are limited by the lack of clinical cardiovascular disease end points.
“Third, conclusions from our study are limited by the lack of CVD clinical end points; however, we assessed CVD risk factors extensively.”
Quote in the paperSubstantial claim - Interpretationcitation
Our results with regard to body weight are consistent with other trials and a recent meta-analysis.
“Our results with regard to body weight are consistent with those of other trials (23, 24) and a recent meta-analysis (25).”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites [23] Shai I Schwarzfuchs D Henkin Y Shahar DR Witkow S Greenberg I Dietary Intervention Randomized Controlled Trial (DIRECT) Group Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet N Engl J Med 2008 359 229 41 10.1056/NEJMoa0708681 18635428 source
Not checked in the free run.
- cites [24] Gardner CD Kiazand A Alhassan S Kim S Stafford RS Balise RR Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women: the A TO Z Weight Loss Study: a randomized trial JAMA 2007 297 969 77 17341711 source
Not checked in the free run.
- cites [25] Hu T Mills KT Yao L Demanelis K Eloustaz M Yancy WS Jr Effects of low-carbohydrate diets versus low-fat diets on metabolic risk factors: a meta-analysis of randomized controlled clinical trials Am J Epidemiol 2012 176 Suppl 7 S44 54 10.1093/aje/kws264 23035144 PMC3530364 source
Not checked in the free run.
- Premisecitation
The cardiovascular effects of low-carbohydrate diets are not well established.
“Low-carbohydrate diets have become a popular strategy for weight loss and weight management in recent years; however, their cardiovascular effects are unknown.”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [2] Halton TL Willett WC Liu S Manson JE Albert CM Rexrode K Low-carbohydrate-diet score and the risk of coronary heart disease in women N Engl J Med 2006 355 1991 2002 17093250 source
Not checked in the free run.
- cites [3] Lagiou P Sandin S Lof M Trichopoulos D Adami HO Weiderpass E Low carbohydrate-high protein diet and incidence of cardiovascular diseases in Swedish women: prospective cohort study BMJ 2012 344 e4026 10.1136/bmj.e4026 22735105 PMC3383863 source
Not checked in the free run.
- Study design and conductown data
Sensitivity analyses using multiple imputation were consistent with the primary analyses.
“Results of sensitivity analyses using multiple imputation techniques to impute missing values were consistent with those presented in our primary analyses.”
Quote in the paperNot a substantial claim - Premisecitation
Prospective cohort studies have yielded conflicting findings on the link between low-carbohydrate dietary patterns and cardiovascular disease risk.
“Prospective cohort studies have produced conflicting results regarding the association between low-carbohydrate dietary patterns and risk for CVD (2, 3).”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [2] Halton TL Willett WC Liu S Manson JE Albert CM Rexrode K Low-carbohydrate-diet score and the risk of coronary heart disease in women N Engl J Med 2006 355 1991 2002 17093250 source
Not checked in the free run.
- cites [3] Lagiou P Sandin S Lof M Trichopoulos D Adami HO Weiderpass E Low carbohydrate-high protein diet and incidence of cardiovascular diseases in Swedish women: prospective cohort study BMJ 2012 344 e4026 10.1136/bmj.e4026 22735105 PMC3383863 source
Not checked in the free run.
- Interpretationreasoning
Findings may not be generalizable to more common situations where intensive and repeated dietary counseling is not available.
“Finally, although our findings show what can be achieved, they may not be generalizable to more common situations where intensive and repeated dietary counseling is not available.”
Quote in the paperNot a substantial claim - Study design and conductown data
Baseline demographic characteristics and cardiovascular risk factors were similar between groups.
“Demographic characteristics and cardiovascular risk factors were similar between groups.”
Quote in the paperSubstantial claim - Premiseown data
The study included a substantial proportion of black participants, a group underrepresented in previous trials.
“Finally, our study included a substantial proportion of black participants, a group underrepresented in previous trials.”
Quote in the paperNot a substantial claim - Premisecitation
The ratio of total to HDL cholesterol is a strong and independent predictor of CHD.
“which has been identified as a strong and independent predictor of CHD (27).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [27] Gardner CD Fortmann SP Krauss RM Association of small low-density lipoprotein particles with the incidence of coronary artery disease in men and women JAMA 1996 276 875 81 8782636
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- Premisecitation
Typical low-carbohydrate diets for weight loss restrict carbohydrate to less than 20% of daily energy intake.
“Typical low-carbohydrate diets for weight loss restrict carbohydrate to less than 20% of daily energy intake (6).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [6] Sacks FM Bray GA Carey VJ Smith SR Ryan DH Anton SD Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates N Engl J Med 2009 360 859 73 10.1056/NEJMoa0804748 19246357 PMC2763382 source
Not checked in the free run.
- Study design and conductreasoning
The power assessment required 55 participants per group to provide 80% power to detect differences in weight change of at least 3% (SD, 5%) between groups, assuming a 2-sided significance level of 0.05.
“Assuming a 2-sided significance level of 0.05, we needed 55 participants per group to provide 80% power to detect differences in weight change of at least 3% (SD, 5%) between the groups.”
Quote in the paperSubstantial claim - Premisecitation
Brinkworth and colleagues reported a nonsignificant difference in Framingham risk score between a modified Atkins-style low-carbohydrate diet and a low-fat diet among 118 participants with abdominal obesity and other metabolic syndrome components.
“Brinkworth and colleagues (19) reported a nonsignificant difference in Framingham risk score between a modified Atkins-style low-carbohydrate diet and a low-fat diet among 118 participants with abdominal obesity and other metabolic syndrome components.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [19] Brinkworth GD Noakes M Buckley JD Keogh JB Clifton PM Long-term effects of a very-low-carbohydrate weight loss diet compared with an isocaloric low-fat diet after 12 mo Am J Clin Nutr 2009 90 23 32 10.3945/ajcn.2008.27326 19439458 source
Not checked in the free run.
- May combine two claims. 21
- Classified as probably not a substantial claim. 21
May combine two claims.
Findingown dataSerum insulin and creatinine decreased significantly in each group, but the decreases did not differ significantly between groups.
“Although serum levels of insulin and creatinine decreased significantly in each group, the decreases did not differ significantly between groups (Table 3).”
Quote in the paperNot a substantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
May combine two claims.
Findingown dataAt 12 months, the low-fat group had significantly higher total carbohydrate intake and significantly lower protein and total, saturated, and monounsaturated fat intake (as percentages of kilocalories) than the low-carbohydrate group (P < 0.001).
“The intake of total carbohydrate was significantly higher and intakes of protein and total, saturated, and monounsaturated fat (as percentages of kilocalories) were significantly lower in the low-fat group at 12 months (P < 0.001 for these comparisons).”
Quote in the paperSubstantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
May combine two claims.
Findingown dataWaist circumference changes were more favorable in the low-carbohydrate group at 3 and 6 months but did not differ significantly at 12 months.
“Changes in waist circumference were more favorable in the low-carbohydrate group at 3 and 6 months but did not differ significantly from those in the low-fat group at 12 months”
Quote in the paperNot a substantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataBecause of the number of tests performed, statistically significant results should be interpreted with caution, particularly P values between 0.01 and 0.05.
“Because of the number of tests performed in the primary analyses, statistically significant results should be interpreted with caution, particularly P values denoting significance levels between 0.01 and 0.05.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenDietitians were not blinded to the study hypothesis.
“Second, dietitians were not blinded to the study hypothesis.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationA recent meta-analysis showed that both low-fat and low-carbohydrate diets reduced LDL cholesterol levels, although the reduction was less for persons assigned to low-carbohydrate diets.
“In contrast, a recent meta-analysis showed that both low-fat and low-carbohydrate diets reduced LDL cholesterol levels, although the reduction was less for persons assigned to low-carbohydrate diets (25).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [25] Hu T Mills KT Yao L Demanelis K Eloustaz M Yancy WS Jr Effects of low-carbohydrate diets versus low-fat diets on metabolic risk factors: a meta-analysis of randomized controlled clinical trials Am J Epidemiol 2012 176 Suppl 7 S44 54 10.1093/aje/kws264 23035144 PMC3530364 source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
InterpretationcitationThe decreases in HDL cholesterol and triglyceride levels observed were within the range reported in previous weight-loss studies.
“The decreases in HDL cholesterol and triglyceride levels that we observed were within the range reported in previous weight-loss studies (25).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [25] Hu T Mills KT Yao L Demanelis K Eloustaz M Yancy WS Jr Effects of low-carbohydrate diets versus low-fat diets on metabolic risk factors: a meta-analysis of randomized controlled clinical trials Am J Epidemiol 2012 176 Suppl 7 S44 54 10.1093/aje/kws264 23035144 PMC3530364 source
Not checked in the free run.
Classified as probably not a substantial claim.
PremisecitationLDL cholesterol is an established risk factor for cardiovascular disease.
“an established risk factor for CVD (8, 28).”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [8] National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report Circulation 2002 106 3143 421 12485966 source
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- cites [28] Ross R Atherosclerosis—an inflammatory disease N Engl J Med 1999 340 115 26 9887164 source
Not checked in the free run.
May combine two claims.
PremisecitationTwo trials examined cardiovascular effects in samples with a majority of black persons but included only diabetic patients or those with severe obesity, most of whom (83%) also had type 2 diabetes or metabolic syndrome.
“Although 2 trials have examined cardiovascular effects in samples with a majority of black persons, they included only diabetic patients or those with severe obesity, most of whom (83%) also had type 2 diabetes or the metabolic syndrome (4, 5).”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [4] Stern L Iqbal N Seshadri P Chicano KL Daily DA McGrory J The effects of low-carbohydrate versus conventional weight loss diets in severely obese adults: one-year follow-up of a randomized trial Ann Intern Med 2004 140 778 85 15148064 source
Not checked in the free run.
- cites [5] Davis NJ Tomuta N Schechter C Isasi CR Segal-Isaacson CJ Stein D Comparative study of the effects of a 1-year dietary intervention of a low-carbohydrate diet versus a low-fat diet on weight and glycemic control in type 2 diabetes Diabetes Care 2009 32 1147 52 10.2337/dc08-2108 19366978 PMC2699720 source
Not checked in the free run.
May combine two claims.
PremisecitationTwo previous studies that examined CRP levels found no difference between the diets; however, both had relatively small sample sizes and may have been underpowered.
“Two previous studies that examined CRP levels found no difference between the diets (19, 29); however, both had relatively small sample sizes and may have been underpowered.”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [19] Brinkworth GD Noakes M Buckley JD Keogh JB Clifton PM Long-term effects of a very-low-carbohydrate weight loss diet compared with an isocaloric low-fat diet after 12 mo Am J Clin Nutr 2009 90 23 32 10.3945/ajcn.2008.27326 19439458 source
Not checked in the free run.
- cites [29] Cardillo S Seshadri P Iqbal N The effects of a low-carbohydrate versus low-fat diet on adipocytokines in severely obese adults: three-year follow-up of a randomized trial Eur Rev Med Pharmacol Sci 2006 10 99 106 16875041
Not checked in the free run.
May combine two claims.
Study design and conductown dataAssessment completion proportions at months 3, 6, and 12 were 93.2%, 87.7%, and 82.2% in the low-fat group and 92.0%, 82.7%, and 78.7% in the low-carbohydrate group.
“The proportions of participants completing assessments at months 3, 6, and 12 were 93.2%, 87.7%, and 82.2%, respectively, in the low-fat group and 92.0%, 82.7%, and 78.7%, respectively, in the low-carbohydrate group”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationPrevious studies had small sample sizes or low completion rates, did not assess a typical low-carbohydrate diet for weight loss, or did not include diverse populations.
“Previous studies have examined the effects of low-carbohydrate diets on CVD risk factors, but most of these trials had small sample sizes or low completion rates, did not assess a typical low-carbohydrate diet for weight loss, or did not include diverse populations (19–24).”
Quote in the paperSubstantial claim0 of 6 sources checked- cites [19] Brinkworth GD Noakes M Buckley JD Keogh JB Clifton PM Long-term effects of a very-low-carbohydrate weight loss diet compared with an isocaloric low-fat diet after 12 mo Am J Clin Nutr 2009 90 23 32 10.3945/ajcn.2008.27326 19439458 source
Not checked in the free run.
- cites [20] Dansinger ML Gleason JA Griffith JL Selker HP Schaefer EJ Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial JAMA 2005 293 43 53 15632335 source
Not checked in the free run.
- cites [21] Foster GD Wyatt HR Hill JO Makris AP Rosenbaum DL Brill C Weight and metabolic outcomes after 2 years on a low-carbohydrate versus low-fat diet: a randomized trial Ann Intern Med 2010 153 147 57 10.7326/0003-4819-153-3-201008030-00005 20679559 PMC2949959 source
Not checked in the free run.
- cites [22] Foster GD Wyatt HR Hill JO McGuckin BG Brill C Mohammed BS A randomized trial of a low-carbohydrate diet for obesity N Engl J Med 2003 348 2082 90 12761365 source
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- cites [23] Shai I Schwarzfuchs D Henkin Y Shahar DR Witkow S Greenberg I Dietary Intervention Randomized Controlled Trial (DIRECT) Group Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet N Engl J Med 2008 359 229 41 10.1056/NEJMoa0708681 18635428 source
Not checked in the free run.
- cites [24] Gardner CD Kiazand A Alhassan S Kim S Stafford RS Balise RR Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women: the A TO Z Weight Loss Study: a randomized trial JAMA 2007 297 969 77 17341711 source
Not checked in the free run.
May combine two claims.
PremisecitationThe few prior trials either did not test a typical low-carbohydrate diet or enrolled severely obese participants, most with type 2 diabetes or metabolic syndrome.
“The few that have either did not assess a typical low-carbohydrate diet or included severely obese participants, most of whom had type 2 diabetes or the metabolic syndrome (4–6).”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [4] Stern L Iqbal N Seshadri P Chicano KL Daily DA McGrory J The effects of low-carbohydrate versus conventional weight loss diets in severely obese adults: one-year follow-up of a randomized trial Ann Intern Med 2004 140 778 85 15148064 source
Not checked in the free run.
- cites [5] Davis NJ Tomuta N Schechter C Isasi CR Segal-Isaacson CJ Stein D Comparative study of the effects of a 1-year dietary intervention of a low-carbohydrate diet versus a low-fat diet on weight and glycemic control in type 2 diabetes Diabetes Care 2009 32 1147 52 10.2337/dc08-2108 19366978 PMC2699720 source
Not checked in the free run.
- cites [6] Sacks FM Bray GA Carey VJ Smith SR Ryan DH Anton SD Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates N Engl J Med 2009 360 859 73 10.1056/NEJMoa0804748 19246357 PMC2763382 source
Not checked in the free run.
May combine two claims.
PremisecitationThe POUNDS LOST study included a substantial number of black persons but did not test a typical low-carbohydrate diet.
“The POUNDS LOST (Preventing Overweight Using Novel Dietary Strategies) study, which examined the effects of 4 diets with different macronutrient compositions, included a substantial number of black persons but did not test a typical low-carbohydrate diet.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [6] Sacks FM Bray GA Carey VJ Smith SR Ryan DH Anton SD Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates N Engl J Med 2009 360 859 73 10.1056/NEJMoa0804748 19246357 PMC2763382 source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenOutcome assessors were blinded to diet group assignment.
“and all outcome assessors were blinded to the diet group assignment.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductown dataCompletion rates were 82% in the low-fat group and 79% in the low-carbohydrate group.
“Sixty participants (82%) in the low-fat group and 59 (79%) in the low-carbohydrate group completed the intervention.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataRandomization used computer-generated blocked allocation stratified by sex.
“We used a computer-generated, blocked randomization, stratified by sex, to allocate participants to 1 of the 2 diet groups.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone givenSelf-reported dietary information may be subject to memory and recall issues, and participants who complete dietary recall may be more likely to report adhering to the interventions.
“First, self-reported dietary information may be subject to memory and recall issues, and participants who complete the dietary recall may be more likely to report adhering to the interventions.”
Quote in the paperNot a substantial claim- Rests on an assumption: Self-reported 24-hour dietary recalls accurately reflect participants' actual dietary intake.
May combine two claims.
Interpretationown dataThe low-carbohydrate diet was more effective for weight loss and cardiovascular risk factor reduction than the low-fat diet.
“The low-carbohydrate diet was more effective for weight loss and cardiovascular risk factor reduction than the low-fat diet.”
- Also stated in: § DISCUSSION · plain
“Our study found that a low-carbohydrate diet induced greater weight loss and reductions in cardiovascular risk factors at 12 months than a low-fat diet among black and white obese adults who did not have diabetes, CVD, or kidney disease at baseline.”
Quote in the paperSubstantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
- Also stated in: § DISCUSSION · plain
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenAll data were collected by trained and certified staff using rigorous quality control protocols.
“All data were collected by trained and certified staff using rigorous quality control protocols.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim. May combine two claims.
Study design and conductown dataThe trial was randomized and parallel-group.
“A randomized, parallel-group trial.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationThe Framingham risk score is a global index of CHD risk used in clinical settings.
“The Framingham risk score is a global index of CHD risk used in clinical settings (8, 17, 30).”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites [8] National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report Circulation 2002 106 3143 421 12485966 source
Not checked in the free run.
- cites [17] Wilson PW D’Agostino RB Levy D Belanger AM Silbershatz H Kannel WB Prediction of coronary heart disease using risk factor categories Circulation 1998 97 1837 47 9603539 source
Not checked in the free run.
- cites [30] US Preventive Services Task Force Aspirin for the prevention of cardiovascular disease: U.S. Preventive Services Task Force recommendation statement Ann Intern Med 2009 150 396 404 19293072 source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenThe funding source had no role in the design, conduct, analysis, or reporting of the study.
“The funding source had no role in the design, conduct, analysis, or reporting of the study.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenThe study assessed cardiovascular risk factors extensively.
“however, we assessed CVD risk factors extensively.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Study design and conductcitationMarkov chain Monte Carlo techniques were used to impute missing values with additional covariates to make the MAR assumption more plausible.
“We used Markovchain Monte Carlo techniques to impute missing values, including additional covariates (age, sex, race, marital status, education, and employment status), in the model to make the MAR assumption more plausible (18).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [18] Molenberghs G Kenward M Missing Data in Clinical Studies Hoboken, NJ J Wiley 2007
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- The authors state this as an assumption: Missing outcome data are missing at random.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductown dataDietary data were collected within 24 hours of consumption and multiple 24-hour recalls were used to reflect weekday and weekend eating patterns.
“However, we collected these within 24 hours of consumption and used multiple 24-hour diet recalls to reflect weekday and weekend eating patterns.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningResults should be interpreted with caution because of difficulty quantifying the exact amount of uncertainty around an individual's risk score.
“Moreover, these results should be interpreted with caution because of difficulty quantifying the exact amount of uncertainty around an individual’s risk score.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Study design and conductreasoningThe sample size of 148 participants allowed for a 25% dropout rate after randomization.
“The sample size of 148 participants allowed for a 25% dropout rate after randomization.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenNo adjustment was made for multiple comparisons.
“All P values were 2-sided, and no adjustment was made for multiple comparisons.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim. May combine two claims.
Study design and conductown dataSensitivity analyses assessed the robustness of conclusions and departures from the MAR assumption.
“We performed sensitivity analyses to assess the robustness of our conclusions and departures from the MAR assumption.”
Quote in the paperSubstantial claim- The authors state this as an assumption: Missing outcome data are missing at random.
May combine two claims.
Study design and conductreasoningSpecific detailed scripts were used for counseling sessions, staff were trained to deliver them without deviation, and sessions were intermittently observed for consistency by an independent registered dietitian consultant.
“In order to avoid potential differences in dietary counseling due to this, we used specific and detailed scripts for all counseling sessions and trained staff to deliver the scripts without deviation.”
- Also stated in: § DISCUSSION · plain
“Dietary sessions for both groups were intermittently observed for consistency by an independent registered dietitian consultant who was not a regular part of the study staff”
Quote in the paperSubstantial claim- Also stated in: § DISCUSSION · plain
May combine two claims.
Study design and conductown dataThe study tested a typical low-carbohydrate dietary intervention with a high completion rate over 12 months and a substantial sample of black persons.
“In contrast, our study tested the effects of a typical low-carbohydrate dietary intervention, with a high completion rate (approximately 80%) over 12 months of follow-up and a substantial sample of black persons (a group under-represented in previous trials).”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductown dataDietary recalls were obtained by a trained and certified staff member, and 5% were recorded and reviewed for quality control.
“All dietary recalls were obtained by a trained and certified staff member.”
- Also stated in: § Data Collection · plain
“Five percent of the dietary recalls were recorded and reviewed for quality control purposes.”
Quote in the paperNot a substantial claim- Also stated in: § Data Collection · plain
May combine two claims.
Study design and conductown dataThe trial included men and women without diabetes and cardiovascular disease at baseline and comprehensively measured cardiovascular risk profiles.
“Unlike some previous studies, our trial included men and women who did not have diabetes and CVD at baseline and comprehensively measured cardiovascular risk profiles.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductown dataThe study was approved by the institutional review board, and each participant signed an approved consent form.
“The study was approved by the institutional review board at Tulane University, and each participant signed an approved consent form.”
Quote in the paperNot a substantial claim
The authors state this as an assumption.
Missing outcome data are missing at random.
“The random-effects model allows the assumption of data missing at random (MAR).”
The paper relies on this without support.
Self-reported 24-hour dietary recalls accurately reflect participants' actual dietary intake.
“Two 24-hour dietary recalls were obtained from participants at baseline and 3, 6, and 12 months to characterize and monitor individual dietary intake of macronutrients.”
“First, self-reported dietary information may be subject to memory and recall issues, and participants who complete the dietary recall may be more likely to report adhering to the interventions.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In analyses excluding studies including subjects with associated metabolic disorders, weighted mean differences were similar to the primary meta-analysis for body weight, TAG, total cholesterol, HDL-cholesterol and LDL-cholesterol.
“In analyses that excluded studies including subjects with associated metabolic disorders (11,28,29,34,37,38) , the WMD was similar as in the primary meta-analysis for body weight (six studies), TAG (six studies), TC (one study), HDL-cholesterol (six studies) and LDL-cholesterol (six studies).”
From Effects of low-carbohydrate diets<i>v</i>. low-fat diets on body weight and cardiovascular risk factors: a meta-analysis of randomised controlled trials (2016) · cites this paper as [34]
The citation identifies Bazzano et al. as a study excluded because it included subjects with associated metabolic disorders. But the Methods (Setting and Participants; page unavailable) say the trial excluded people with clinical cardiovascular disease, type 2 diabetes, or kidney disease, and describe its population as having no clinical comorbid conditions. This paper also reports a single trial, not the cited weighted-mean-difference sensitivity analysis. (LLM, conf=0.88)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredStudies utilizing carbohydrate restriction observed improved glycemic control and cardiometabolic markers, but were often short-term trials of small groups, excluded subjects prescribed insulin, or infrequently monitored or achieved ketosis.
“Studies utilizing carbohydrate restriction observed improved glycemic control and cardiometabolic markers, but were often short-term trials of small groups, excluded subjects prescribed insulin, or infrequently monitored or achieved ketosis [16–20].”
From Effectiveness and Safety of a Novel Care Model for the Management of Type 2 Diabetes at 1 Year: An Open-Label, Non-Randomized, Controlled Study (2018) · cites this paper as [20]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Conflicting P values for the 12-month weight difference
MinorThe abstract reports P < 0.001 for the −3.5 kg between-group difference, while the results section reports P = 0.002 for the same estimate and confidence interval.
“mean difference in change, −3.5 kg [95% CI, −5.6 to −1.4 kg]; P < 0.001”
“mean difference in change at 12 months, −3.5 kg [95% CI, −5.6 to −1.4 kg]; P = 0.002”
The citation lists haven’t been fetched yet
References 41 · Cited by 346
Research works printed but not linked: 1
- Cardillo S, 2006, Eur Rev Med Pharmacol Sci, 10, 99
- Authors
- Bazzano, L. A., Hu, T., Reynolds, K., Yao, L., Bunol, C., Liu, Y., Chen, C.-S., Klag, M. J., Whelton, P. K., & He, J.
- Affiliations
- Tulane University (US)
- ORCID
- Venue
- Annals of Internal Medicine
- Publisher
- American College of Physicians
- Published
- 2014-09-02
- Volume
- 161
- Issue
- 5
- Pages
- 309-318
- ISSN
- 0003-4819 (ISSN-L)
- 1539-3704
- PMC
- PMC4428290
- OpenAlex
- W2101149495
- Semantic Scholar
- ab86293d56df62a044c7a0d86f3c02b38c18aeb1
- Cited by
- 346
- References
- 41
- Citations by year
- 2026: 13 · 2025: 29 · 2024: 21 · 2023: 24 · 2022: 28 · 2021: 29 · 2020: 37 · 2019: 23 · 2018: 29 · 2017: 31 · 2016: 30 · 2015: 43 · 2014: 8 · 2012: 1
- FWCI
- 24.89
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Annals of Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Tulane University
- National Institutes of Health
- National Institute of General Medical Sciences (P30GM103337)
- National Center for Research Resources (P20RR017659)
- Topics
- Health Sciences › Medicine › Physiology › Diet and metabolism studies
- Health Sciences › Medicine › Physiology › Dietary Effects on Health
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutritional Studies and Diet
- Keywords
- low-carbohydrate diet, low-fat diet, weight loss, cardiovascular risk factors, HDL cholesterol, triglycerides, fat mass, nutrition counseling, saturated fat, dietary fat intake, cardiovascular disease prevention, diabetes prevention, dietary adherence, participant retention, participant recruitment, participant satisfaction
- MeSH terms
- Adult, Aged, Blood Glucose, Blood Pressure, C-Reactive Protein, Cardiovascular Diseases, Creatinine, Female, Humans, Insulin, Cholesterol, HDL, Cholesterol, LDL, Male, Middle Aged, Obesity, Risk Factors, Triglycerides, Weight Loss, Diet, Fat-Restricted, Diet, Carbohydrate-Restricted, Waist Circumference, Young Adult
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-06.
Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-06.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
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