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Randomized Controlled Trial
. 2020 Nov 2;3(11):e2025454.
doi: 10.1001/jamanetworkopen.2020.25454.

Effect of a Low-Fat Vegan Diet on Body Weight, Insulin Sensitivity, Postprandial Metabolism, and Intramyocellular and Hepatocellular Lipid Levels in Overweight Adults: A Randomized Clinical Trial

Hana Kahleova  1 , Kitt Falk Petersen  2 , Gerald I Shulman  2   3 , Jihad Alwarith  1 , Emilie Rembert  1 , Andrea Tura  4 , Martin Hill  5 , Richard Holubkov  6 , Neal D Barnard  1   7
Affiliations
Randomized Controlled Trial

Effect of a Low-Fat Vegan Diet on Body Weight, Insulin Sensitivity, Postprandial Metabolism, and Intramyocellular and Hepatocellular Lipid Levels in Overweight Adults: A Randomized Clinical Trial

Hana Kahleova et al. JAMA Netw Open. .

Erratum in

  • Clarification of Role of Funder Statement.
    [No authors listed] [No authors listed] JAMA Netw Open. 2021 Jan 4;4(1):e2035088. doi: 10.1001/jamanetworkopen.2020.35088. JAMA Netw Open. 2021. PMID: 33410873 Free PMC article. No abstract available.
  • Errors in Abstract and Main Results.
    [No authors listed] [No authors listed] JAMA Netw Open. 2021 Feb 1;4(2):e210550. doi: 10.1001/jamanetworkopen.2021.0550. JAMA Netw Open. 2021. PMID: 33523186 Free PMC article. No abstract available.
  • Error in the Results and eTable 2 in Supplement 2.
    [No authors listed] [No authors listed] JAMA Netw Open. 2021 May 3;4(5):e2115510. doi: 10.1001/jamanetworkopen.2021.15510. JAMA Netw Open. 2021. PMID: 34043000 Free PMC article. No abstract available.

Abstract

Importance: Excess body weight and insulin resistance lead to type 2 diabetes and other major health problems. There is an urgent need for dietary interventions to address these conditions.

Objective: To measure the effects of a low-fat vegan diet on body weight, insulin resistance, postprandial metabolism, and intramyocellular and hepatocellular lipid levels in overweight adults.

Design, setting, and participants: This 16-week randomized clinical trial was conducted between January 2017 and February 2019 in Washington, DC. Of 3115 people who responded to flyers in medical offices and newspaper and radio advertisements, 244 met the participation criteria (age 25 to 75 years; body mass index of 28 to 40) after having been screened by telephone.

Interventions: Participants were randomized in a 1:1 ratio. The intervention group (n = 122) was asked to follow a low-fat vegan diet and the control group (n = 122) to make no diet changes for 16 weeks.

Main outcomes and measures: At weeks 0 and 16, body weight was assessed using a calibrated scale. Body composition and visceral fat were measured by dual x-ray absorptiometry. Insulin resistance was assessed with the homeostasis model assessment index and the predicted insulin sensitivity index (PREDIM). Thermic effect of food was measured by indirect calorimetry over 3 hours after a standard liquid breakfast (720 kcal). In a subset of participants (n = 44), hepatocellular and intramyocellular lipids were quantified by proton magnetic resonance spectroscopy. Repeated measure analysis of variance was used for statistical analysis.

Results: Among the 244 participants in the study, 211 (87%) were female, 117 (48%) were White, and the mean (SD) age was 54.4 (11.6) years. Over the 16 weeks, body weight decreased in the intervention group by 5.9 kg (95% CI, 5.0-6.7 kg; P < .001). Thermic effect of food increased in the intervention group by 14.1% (95% CI, 6.5-20.4; P < .001). The homeostasis model assessment index decreased (-1.3; 95% CI, -2.2 to -0.3; P < .001) and PREDIM increased (0.9; 95% CI, 0.5-1.2; P < .001) in the intervention group. Hepatocellular lipid levels decreased in the intervention group by 34.4%, from a mean (SD) of 3.2% (2.9%) to 2.4% (2.2%) (P = .002), and intramyocellular lipid levels decreased by 10.4%, from a mean (SD) of 1.6 (1.1) to 1.5 (1.0) (P = .03). None of these variables changed significantly in the control group over the 16 weeks. The change in PREDIM correlated negatively with the change in body weight (r = -0.43; P < .001). Changes in hepatocellular and intramyocellular lipid levels correlated with changes in insulin resistance (both r = 0.51; P = .01).

Conclusions and relevance: A low-fat plant-based dietary intervention reduces body weight by reducing energy intake and increasing postprandial metabolism. The changes are associated with reductions in hepatocellular and intramyocellular fat and increased insulin sensitivity.

Trial registration: ClinicalTrials.gov Identifier: NCT02939638.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Kahleova reported being director of clinical research at the Physicians Committee, a nonprofit organization that provides nutrition education and research. Dr Rembert reported compensation from the Physicians Committee for Responsible Medicine outside the submitted work. Dr Holubkov reported receiving personal fees from the Physicians Committee for Responsible Medicine during the conduct of the study. Dr Barnard reported to serving as president of the Physicians Committee for Responsible Medicine and Barnard Medical Center; receiving royalties from Hachette Book Group, Penguin Random House, Rodale, and Da Capo publishers; and receiving honoraria from Yale, Rush, George Washington, Loma Linda, Rockford Universities, Montefiore Medical Center, the Mayo Clinic, Northwell Health, Christiana Care, Oticon, and the National Organization of Professional Athletes. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram of Participant Flow Through Trial
Figure 2.
Figure 2.. Changes in the Thermic Effect of Food, Liver Fat, and Intramyocellular Lipid Levels in the Intervention and Control Groups
Whiskers represent 95% CIs.
See this image and copyright information in PMC

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