The effect of high-protein, low-carbohydrate diets in the treatment of type 2 diabetes: a 12 month randomised controlled trial
Open accessAbstract
Aims/hypothesis Short-term dietary studies suggest that high-protein diets can enhance weight loss and improve glycaemic control in people with type 2 diabetes. However, the long-term effects of such diets are unknown. The aim of this study was to determine whether high-protein diets are superior to high-carbohydrate diets for improving glycaemic control in individuals with type 2 diabetes. Methods Overweight/obese individuals (BMI 27-40 kg/m(2)) with type 2 diabetes (HbA(1c) 6.5-10%) were recruited for a 12 month, parallel design, dietary intervention trial conducted at a diabetes specialist clinic (Melbourne, VIC, Australia). Of the 108 initially randomised, 99 received advice to follow low-fat (30% total energy) diets that were either high in protein (30% total energy, n = 53) or high in carbohydrate (55% total energy, n = 46). Dietary assignment was done by a third party using computer-generated random numbers. The primary endpoint was change in HbA(1c). Secondary endpoints included changes in weight, lipids, blood pressure, renal function and calcium loss. Study endpoints were assessed blinded to the diet group, but the statistical analysis was performed unblinded. This study used an intention-to-treat model for all participants who received dietary advice. Follow-up visits were encouraged regardless of dietary adherence and last measurements were carried forward for study non-completers. Results Ninety-nine individuals were included in the analysis (53 in high protein group, 46 in high carbohydrate group). HbA(1c) decreased in both groups over time, with no significant difference between groups (mean difference of the change at 12 months; 0.04 [95% CI -0.37, 0.46]; p = 0.44). Both groups also demonstrated decreases over time in weight, serum triacylglycerol and total cholesterol, and increases in HDL-cholesterol. No differences in blood pressure, renal function or calcium loss were seen. Conclusions/interpretation These results suggest that there is no superior long-term metabolic benefit of a high-protein diet over a high-carbohydrate in the management of type 2 diabetes. Trial registration ACTRN12605000063617 ( www.anzctr.org.au ). Funding This study was funded by a nutritional research grant from Meat and Livestock Australia (MLA). J.E. Shaw is supported by NHMRC Fellowship 586623.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
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 a recent study of older patients with moderate Type 2 diabetes but no kidney disease, those who ate a high-protein diet (about 30% kcal from protein) tended to require fewer glucose-lowering medications after 1 year compared with baseline.
“However, a recent study of older patients (upper age limit: 75 years) with moderate Type 2 diabetes (HbA 1c about 7.9%) but no kidney disease, showed that those who ate a high-protein diet (about 30% kcal from protein) tended to require fewer glucose-lowering medications after 1 year, compared with their baseline medication levels.105”
From Evidence-Based Recommendations for Optimal Dietary Protein Intake in Older People: A Position Paper From the PROT-AGE Study Group (2013) · cites this paper as [105]
Cites
A Low-Carbohydrate as Compared with a Low-Fat Diet in Severe Obesity
Samaha, F. F., Iqbal, N., Seshadri, P., Chicano, K. L., Daily, D. A., McGrory, J., Williams, T., Williams, M., Gracely, E. J., & Stern, L. (2003) · New England Journal of Medicine · doi:10.1056/nejmoa022637 · Cited by 1,267 · cited 2× · see citing works
“After 12 months of following the prescribed diet, there was no significant difference between groups in median dietary self-management scores (median [interquartile range]; 4 [3, 4] for HP vs 4 [3, 4] for HC, p=0.”
BackgroundNordmann, A. J., Nordmann, A., Briel, M., Keller, U., Yancy, W. S., Brehm, B. J., & Bucher, H. C. (2006) · Archives of Internal Medicine · doi:10.1001/archinte.166.3.285 · Cited by 973 · see citing works
Brinkworth, G. D., Noakes, M., Keogh, J. B., Luscombe, N. D., Wittert, G. A., & Clifton, P. M. (2004) · International Journal of Obesity · doi:10.1038/sj.ijo.0802617 · Cited by 245 · see citing works
Nielsen, J. V., Jönsson, E., & Nilsson, A.-K. (2005) · Upsala Journal of Medical Sciences · doi:10.3109/2000-1967-182 · Cited by 52 · see citing works
Gutierrez, M., Akhavan, M., Jovanovic, L., & Peterson, C. M. (1998) · Journal of the American College of Nutrition · doi:10.1080/07315724.1998.10718808 · Cited by 37 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Standards of medical care in diabetes—2014
American Diabetes Association (2014) · Diabetes Care · doi:10.2337/dc14-s014 · Cited by 4,572 · see citing works
Bauer, J., Biolo, G., Cederholm, T., Cesari, M., Cruz-Jentoft, A. J., Morley, J. E., Phillips, S., Sieber, C., Stehle, P., Teta, D., et al. (2013) · Journal of the American Medical Directors Association · doi:10.1016/j.jamda.2013.05.021 · Cited by 2,553 · see citing works
Garvey, W. T., Mechanick, J. I., Brett, E. M., Garber, A. J., Hurley, D. L., Jastreboff, A. M., Nadolsky, K., Pessah-Pollack, R., & Plodkowski, R. (2016) · Endocrine Practice · doi:10.4158/ep161365.gl · Cited by 1,914 · see citing works
Nutrition therapy recommendations for the management of adults with diabetes
Evert, A. B., Boucher, J. L., Cypress, M., Dunbar, S. A., Franz, M. J., Mayer-Davis, E. J., Neumiller, J. J., Nwankwo, R., Verdi, C. L., Urbanski, P., et al. (2013) · Diabetes Care · doi:10.2337/dc13-2042 · Cited by 1,129 · see citing works
Ajala, O., English, P., & Pinkney, J. (2013) · The American Journal of Clinical Nutrition · doi:10.3945/ajcn.112.042457 · Cited by 821 · see citing works
Nutrition therapy recommendations for the management of adults with diabetes
Evert, A. B., Boucher, J. L., Cypress, M., Dunbar, S. A., Franz, M. J., Mayer-Davis, E. J., Neumiller, J. J., Nwankwo, R., Verdi, C. L., Urbanski, P., et al. (2014) · Diabetes Care · doi:10.2337/dc14-s120 · Cited by 766 · see citing works
Franz, M. J., Boucher, J. L., Rutten-Ramos, S., & VanWormer, J. J. (2015) · Journal of the Academy of Nutrition and Dietetics · doi:10.1016/j.jand.2015.02.031 · Cited by 672 · see citing works
The role of protein in weight loss and maintenance
Leidy, H. J., Clifton, P. M., Astrup, A., Wycherley, T. P., Westerterp-Plantenga, M. S., Luscombe-Marsh, N. D., Woods, S. C., & Mattes, R. D. (2015) · The American Journal of Clinical Nutrition · doi:10.3945/ajcn.114.084038 · Cited by 475 · see citing works
Leitner, D. R., Frühbeck, G., Yumuk, V., Schindler, K., Micic, D., Woodward, E., & Toplak, H. (2017) · Obesity Facts · doi:10.1159/000480525 · Cited by 431 · see citing works
Kirkpatrick, C. F., Bolick, J. P., Kris-Etherton, P. M., Sikand, G., Aspry, K. E., Soffer, D. E., Willard, K.-E., & Maki, K. C. (2019) · Journal of Clinical Lipidology · doi:10.1016/j.jacl.2019.08.003 · Cited by 390 · see citing works
Emerging perspectives on essential amino acid metabolism in obesity and the insulin-resistant state
Adams, S. H. (2011) · Advances in Nutrition · doi:10.3945/an.111.000737 · Cited by 394 · see citing works
Snorgaard, O., Poulsen, G. M., Andersen, H. K., & Astrup, A. (2017) · BMJ Open Diabetes Research & Care · doi:10.1136/bmjdrc-2016-000354 · Cited by 351 · see citing works
The Effects of High-Protein Diets on Kidney Health and Longevity
Ko, G.-J., Rhee, C. M., Kalantar-Zadeh, K., & Joshi, S. (2020) · Journal of the American Society of Nephrology · doi:10.1681/asn.2020010028 · Cited by 345 · see citing works
Frailty and sarcopenia - newly emerging and high impact complications of diabetes
Sinclair, A. J., Abdelhafiz, A. H., & Rodríguez-Mañas, L. (2017) · Journal of Diabetes and its Complications · doi:10.1016/j.jdiacomp.2017.05.003 · Cited by 276 · see citing works
Schwingshackl, L., Chaimani, A., Hoffmann, G., Schwedhelm, C., & Boeing, H. (2018) · European Journal of Epidemiology · doi:10.1007/s10654-017-0352-x · Cited by 273 · see citing works
Sainsbury, E., Kizirian, N. V., Partridge, S. R., Gill, T., Colagiuri, S., & Gibson, A. A. (2018) · Diabetes Research and Clinical Practice · doi:10.1016/j.diabres.2018.02.026 · Cited by 268 · see citing works
Naude, C. E., Schoonees, A., Senekal, M., Young, T., Garner, P., & Volmink, J. (2014) · PLoS ONE · doi:10.1371/journal.pone.0100652 · Cited by 252 · see citing works
Papamichou, D., Panagiotakos, D. B., & Itsiopoulos, C. (2019) · Nutrition, Metabolism and Cardiovascular Diseases · doi:10.1016/j.numecd.2019.02.004 · Cited by 182 · see citing works
Schwingshackl, L., & Hoffmann, G. (2013) · Nutrition Journal · doi:10.1186/1475-2891-12-48 · Cited by 184 · see citing works
Huntriss, R., Campbell, M., & Bedwell, C. (2018) · European Journal of Clinical Nutrition · doi:10.1038/s41430-017-0019-4 · Cited by 170 · see citing works
Gummesson, A., Nyman, E., Knutsson, M., & Karpefors, M. (2017) · Diabetes Obesity and Metabolism · doi:10.1111/dom.12971 · Cited by 162 · see citing works
Dietary Approaches to the Treatment of Obesity
Makris, A., & Foster, G. D. (2011) · Psychiatric Clinics of North America · doi:10.1016/j.psc.2011.08.004 · Cited by 154 · see citing works
Korsmo‐Haugen, H., Brurberg, K. G., Mann, J., & Aas, A. (2019) · Diabetes, Obesity and Metabolism · doi:10.1111/dom.13499 · Cited by 115 · see citing works
Insulin-associated weight gain in obese type 2 diabetes mellitus patients: What can be done?
Brown, A., Guess, N., Dornhorst, A., Taheri, S., & Frost, G. (2017) · Diabetes, Obesity and Metabolism · doi:10.1111/dom.13009 · Cited by 113 · see citing works
Devries, M. C., Sithamparapillai, A., Brimble, K. S., Banfield, L., Morton, R. W., & Phillips, S. M. (2018) · The Journal of Nutrition · doi:10.1093/jn/nxy197 · Cited by 108 · see citing works
A critical review of low‐carbohydrate diets in people with Type 2 diabetes
van Wyk, H. J., Davis, R. E., & Davies, J. S. (2016) · Diabetic Medicine · doi:10.1111/dme.12964 · Cited by 105 · see citing works
Shang, X., Scott, D., Hodge, A., English, D. R., Giles, G. G., Ebeling, P. R., & Sanders, K. M. (2017) · Clinical Nutrition · doi:10.1016/j.clnu.2016.09.024 · Cited by 93 · see citing works
Fechner, E., Smeets, E., Schrauwen, P., & Mensink, R. (2020) · Nutrients · doi:10.3390/nu12040991 · Cited by 64 · see citing works
Emadian, A., Andrews, R. C., England, C. Y., Wallace, V., & Thompson, J. L. (2015) · British Journal of Nutrition · doi:10.1017/s0007114515003475 · Cited by 61 · see citing works
McArdle, P. D., Greenfield, S. M., Rilstone, S. K., Narendran, P., Haque, M. S., & Gill, P. S. (2019) · Diabetic Medicine · doi:10.1111/dme.13862 · Cited by 60 · see citing works
The Effects of Different Quantities and Qualities of Protein Intake in People with Diabetes Mellitus
Pfeiffer, A. F. H., Pedersen, E., Schwab, U., Risérus, U., Aas, A.-M., Uusitupa, M., Thanopoulou, A., Kendall, C., Sievenpiper, J. L., Kahleová, H., et al. (2020) · Nutrients · doi:10.3390/nu12020365 · Cited by 60 · see citing works
Sofer, S., Stark, A. H., & Madar, Z. (2015) · Advances in Nutrition · doi:10.3945/an.114.007518 · Cited by 39 · see citing works
High protein diet is of benefit for patients with type 2 diabetes: An updated meta-analysis
Zhao, W.-T., Luo, Y., Zhang, Y., Zhou, Y., & Zhao, T.-T. (2018) · Medicine · doi:10.1097/md.0000000000013149 · Cited by 38 · see citing works
Huang, T., Ley, S. H., Zheng, Y., Wang, T., Bray, G. A., Sacks, F. M., & Qi, L. (2016) · The American Journal of Clinical Nutrition · doi:10.3945/ajcn.115.121186 · Cited by 37 · see citing works
Dietary protein in weight management: a review proposing protein spread and change theories
Bosse, J. D., & Dixon, B. M. (2012) · Nutrition & Metabolism · doi:10.1186/1743-7075-9-81 · Cited by 31 · see citing works
Kloecker, D. E., Zaccardi, F., Baldry, E., Davies, M. J., Khunti, K., & Webb, D. R. (2019) · Diabetes, Obesity and Metabolism · doi:10.1111/dom.13727 · Cited by 25 · see citing works
- Authors
- Larsen, R. N., Mann, N. J., Maclean, E., & Shaw, J. E.
- Affiliations
- Baker Heart and Diabetes Institute (AU)
- RMIT University (AU)
- Corresponding author
- Larsen, R. N.
- Venue
- Diabetologia
- Published
- 2011-01-20
- Volume
- 54
- Issue
- 4
- Pages
- 731-740
- ISSN
- 0012-186X (ISSN-L)
- 1432-0428
- OpenAlex
- W2005138391
- Cited by
- 197
- References
- 5
- Citations by year
- 2026: 4 · 2025: 8 · 2024: 8 · 2023: 8 · 2022: 15 · 2021: 8 · 2020: 15 · 2019: 15 · 2018: 18 · 2017: 10 · 2016: 23 · 2015: 19 · 2014: 9 · 2013: 18 · 2012: 15
- FWCI
- 10.04
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Diabetologia (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- GlaxoSmithKline
- Meat and Livestock Australia
- Institut National de la Santé et de la Recherche Médicale
- RMIT University
- Novo Nordisk
- National Health and Medical Research Council (586623)
- Topics
- Health Sciences › Medicine › Physiology › Diet and metabolism studies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- type 2 diabetes, high-protein diet, low-carbohydrate diet, high-carbohydrate diet, glycemic control, HbA1c, weight loss, overweight and obesity, lipid profile, HDL cholesterol, triglycerides, blood pressure, renal function, calcium loss, dietary intervention, long-term dietary effects
- MeSH terms
- Adult, Aged, Diabetes Mellitus, Type 2, Dietary Proteins, Female, Humans, Male, Middle Aged, Diet, Carbohydrate-Restricted
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.
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.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review