Randomized controlled trial testing the effects of weight loss on nonalcoholic steatohepatitis
Open accessAbstract
Nonalcoholic steatohepatitis (NASH) is a chronic progressive liver disease that is strongly associated with obesity. Currently, there is no approved therapy for NASH. Weight reduction is typically recommended, but efficacy data are lacking. We performed a randomized controlled trial to examine the effects of lifestyle intervention using a combination of diet, exercise, and behavior modification, with a goal of 7% to 10% weight reduction, on clinical parameters of NASH. The primary outcome measure was the change in NASH histological activity score (NAS) after 48 weeks of intervention. Thirty-one overweight or obese individuals (body mass index [BMI], 25–40 kg/m2) with biopsy-proven NASH were randomized in a 2:1 ratio to receive intensive lifestyle intervention (LS) or structured education (control). After 48 weeks of intervention, participants assigned to LS lost an average of 9.3% of their weight versus 0.2% in the control group ( P = 0.003). A higher proportion of participants in the LS group had a reduction of NAS of at least 3 points or had posttreatment NAS of 2 or less as compared with the control group (72% versus 30%, P = 0.03). NAS improved significantly in the LS group (from 4.4 to 2.0) in comparison with the control group (from 4.9 to 3.5) ( P = 0.05). Percent weight reduction correlated significantly with improvement in NAS ( r = 0.497, P = 0.007). Participants who achieved the study weight loss goal (≥7%), compared with those who lost less than 7%, had significant improvements in steatosis (−1.36 versus −0.41, P < 0.001), lobular inflammation (−0.82 versus −0.24, P = 0.03), ballooning injury (−1.27 versus −0.53, P = 0.03) and NAS (−3.45 versus −1.18, P < 0.001). Conclusion: Weight reduction achieved through lifestyle intervention leads to improvements in liver histology in NASH. (Hepatology 2009.)
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In people with type 2 diabetes and ABCD, improvements in A1C, blood pressure, and lipids require more than 5% weight loss and are progressive up to and exceeding 15% weight loss, whereas other common complications of ABCD, such as obstructive sleep apnea and NASH, may require more than 10% weight loss for clinical benefits.
“In persons with T2D and ABCD, improvements in A1C, BP, and lipids require >5% weight loss and are progressive up to and exceeding 15% weight loss,678,679 whereas other common complications of ABCD, such as OSA and NASH, may require >10% weight loss for clinical benefits.680–685”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [679]
Split into 2 atoms — 0 confirmed, 0 partially supported, 2 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
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Experimental — accuracy not yet measuredWeight loss of more than 5% to at least 10% or more is needed to achieve progressive and optimal improvements in A1C, blood pressure, and lipids in people with type 2 diabetes and ABCD.
“Weight loss of >5% to ≥10% or more is needed to achieve progressive and optimal improvements in A1C, BP, and lipids in persons with T2D and ABCD.678,679”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [679]
The Weight Change section reports that the intervention group lost an average of 9.3% of body weight at 48 weeks, and Table 2 reports a decrease in mean HbA1c, but the between-group HbA1c difference was not significant (P = 0.52). The paper links at least 7% weight loss to improvements in NASH histology, not to progressive or optimal improvements in A1C, blood pressure, and lipids among people with type 2 diabetes and ABCD. It does not establish the claimed weight-loss threshold for those outcomes. (LLM, conf=0.85)
Experimental — accuracy not yet measuredFor most people with type 2 diabetes, optimal management requires losing more than 5% and up to at least 10% of body weight to improve glycemia and address the risk, presence, and severity of ABCD cardiometabolic and biomechanical complications.
“Weight loss >5% to ≥10% is required for optimal treatment of most persons with T2D to optimally improve glycemia and address the risk, presence, and severity of ABCD cardiometabolic and biomechanical complications.678–683”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [679]
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 measuredLifestyle therapy is a foundational treatment for people with diabetes who have or are at risk for other cardiometabolic outcomes.
“Lifestyle therapy is a foundational aspect of treatment in persons with DM who also may have or are at risk of other CMD outcomes. All persons with DM should be instructed and supported in lifestyle interventions centered around MNT.679,899–901”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [679]
The Discussion (page unavailable) presents lifestyle intervention as an attractive therapy for NASH and notes additional benefits of weight loss for cardiovascular risk factors. The Characteristics of the Participants section (page unavailable) says 48% had type 2 diabetes. The paper does not establish that lifestyle therapy is foundational treatment for people with diabetes generally or across other cardiometabolic conditions. (LLM, conf=0.85)
Experimental — accuracy not yet measuredMultiple whole-food meal patterns improve glycemia, blood pressure, and cardiovascular risk factors in diabetes.
“Regarding whole foods, multiple meal patterns have been shown to be advantageous for the management of DM, which promote reductions in glycemia, BP, and CVD risk factors.679,901,920–924”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [679]
The Lifestyle Intervention section (page unavailable) describes one calorie-restricted diet combined with exercise, not multiple whole-food meal patterns. Table 2 (page unavailable) shows reduced waist circumference and numerical declines in glucose and HbA1c, but the glycemic changes did not differ significantly from controls. The trial enrolled people with nonalcoholic steatohepatitis, about half of whom had diabetes, and does not establish a blood-pressure reduction. (LLM, conf=0.86)
Experimental — accuracy not yet measured
Minimal differences in weight loss between reduced-calorie diets with different macronutrient composition allow health care professionals to personalize recommendations for foods and macronutrients on the basis of individual medical conditions, cultural and personal preferences, lifestyle, and behaviors.
“Minimal differences in weight loss between reduced-calorie diets with different macronutrient composition allow health care professionals to personalize recommendations for foods and macronutrients on the basis of individual medical conditions, cultural and personal preferences, lifestyle, and behaviors.679”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [679]
Split into 2 atoms — 0 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 2 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredContinued medical nutrition therapy support helps maintain glycemic improvements and is accompanied by cost savings.
“Ongoing MNT support is helpful in maintaining glycemic improvements679,901,902,909–912 accompanied by cost savings in a person’s care.913–915”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [679]
The Lifestyle Intervention section describes ongoing nutrition and behavioral support, but the paper studies weight loss and NASH outcomes, not whether medical nutrition therapy maintains glycemic improvements. Its 48-week results table reports glucose and HbA1c values without a significant difference in change between groups. No passage found addresses care cost savings, the part of the citing sentence nearest this citation. (LLM, conf=0.76)
Experimental — accuracy not yet measuredCurrent evidence has not established an ideal macronutrient distribution, such as percentage of calories from carbohydrate, protein, and fat, that can be broadly prescribed for diabetes.
“To achieve dietary goals in DM, studies have demonstrated that there is no ideal mix of macronutrients that can be broadly prescribed, and that current evidence has not established an ideal percentage of calories from carbohydrate, protein, and fat.679,901,919”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [679]
The Lifestyle Intervention section describes a calorie-restricted diet with a 25% fat goal for participants with NASH; it does not assess whether any macronutrient mix is ideal for diabetes generally. Searches for an ideal carbohydrate, protein, and fat distribution found no passage addressing that claim in our copy. (LLM, conf=0.76)
Experimental — accuracy not yet measuredWhen no deficiency exists, routine vitamin and mineral supplements are unnecessary because a healthy eating plan usually supplies enough micronutrients.
“In the absence of underlying insufficiency, routine supplementation of vitamins and minerals is not necessary; a healthful eating meal plan can generally provide sufficient micronutrients.679,935”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [679]
The Lifestyle Intervention section describes meal plans and healthy-eating instruction, but does not assess whether they provide sufficient micronutrients or whether vitamin and mineral supplements are unnecessary. Searches for supplementation, deficiencies, and micronutrient adequacy found no passage addressing those points; page numbers were not available in our copy. (LLM, conf=0.72)
Experimental — accuracy not yet measuredEvidence does not support or is conflicting for chromium, vanadium, magnesium, vitamins A, C, and E, CoQ10, and herbal supplements including cinnamon, curcumin, or aloe vera for improving glycemia in people with diabetes.
“Specifically, chromium; vanadium; magnesium; vitamins A, C, and E; CoQ10; and herbal supplements including cinnamon, curcumin, or aloe vera for improving glycemia in persons with DM are not supported by evidence, or the data are conflicting, and, therefore, are not recommended.679,935”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [679]
The Management of Diabetes Medications section discusses prescription drugs and lifestyle-related hypoglycemia, not the listed supplements. Searches for chromium, vanadium, cinnamon, curcumin, aloe vera, vitamins, and CoQ10 found no passage assessing their evidence for improving glycemia in people with diabetes. The References section mentions a vitamin E study concerning NASH, but does not address this claim. (LLM, conf=0.76)
Experimental — accuracy not yet measuredAn intensive lifestyle intervention program can produce a 7%-10% weight reduction and significant improvements in liver chemistry and histological activity in patients with NASH.
“An intensive lifestyle intervention program can successfully produce a 7%–10% weight reduction and significant improvements in liver chemistry and histological activity in patients with NASH (420).”
From Lack of Exercise Is a Major Cause of Chronic Diseases (2012) · cites this paper as [420]
In patients with NAFLD, a modest weight loss can produce a significant decrease in liver fat content, with improved serum aminotransferase activity and beneficial health effects.
“In patients with NAFLD, a modest weight loss can produce a significant decrease in liver fat content, with improved serum aminotransferase activity and beneficial health effects [69,70].”
From Mediterranean diet nutrients to turn the tide against insulin resistance and related diseases (2020) · cites this paper as [70]
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- Authors
- Promrat, K., Kleiner, D. E., Niemeier, H. M., Jackvony, E., Kearns, M., Wands, J. R., Fava, J. L., & Wing, R. R.
- Affiliations
- Brown University (US)
- National Institutes of Health (US)
- University of Wisconsin–Whitewater (US)
- Corresponding author
- Promrat, Kittichai
- Venue
- Hepatology
- Published
- 2010-01
- Volume
- 51
- Issue
- 1
- Pages
- 121-129
- ISSN
- 0270-9139 (ISSN-L)
- PMC
- PMC2799538
- OpenAlex
- W1997425045
- Cited by
- 1,330
- References
- 43
- Citations by year
- 2026: 47 · 2025: 62 · 2024: 68 · 2023: 102 · 2022: 96 · 2021: 113 · 2020: 95 · 2019: 79 · 2018: 76 · 2017: 93 · 2016: 95 · 2015: 93 · 2014: 94 · 2013: 65 · 2012: 66
- FWCI
- 33.34
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Hepatology (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health
- National Cancer Institute
- National Institute of Diabetes and Digestive and Kidney Diseases (5R03DK67263-2, R03DK067263)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- nonalcoholic steatohepatitis, weight loss, lifestyle intervention, obesity, steatosis, lobular inflammation, diet and exercise, behavior modification, liver histopathology
- MeSH terms
- Adult, Fatty Liver, Female, Humans, Life Style, Liver, Male, Middle Aged, Obesity, Weight Loss
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