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Abstract Details
Effect of Calorie-Unrestricted Low-Carbohydrate, High-Fat Diet Versus High-Carbohydrate, Low-Fat Diet on Type 2 Diabetes and Nonalcoholic Fatty Liver Disease : A Randomized Controlled Trial
Ann Intern Med. 2023 Jan;176(1):10-21. doi: 10.7326/M22-1787.Epub 2022 Dec 13.
1Department of Gastroenterology and Hepatology, Odense University Hospital, and Institute of Clinical Research, University of Southern Denmark, Odense, Denmark (C.D.H., M.B.H., N.T., M.K., S.J., K.H.T., M.S.T.).
2Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark (E.M.G., H.B., K.H.).
3Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark (J.K.H., B.S.M., J.M.J., S.O., D.N.R., P.A., M.I.).
4Department of Gastroenterology and Hepatology, Odense University Hospital, and Institute of Clinical Research, University of Southern Denmark, Odense SV, Denmark (K.P.L.).
5Department of Sport Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark (J.C.B.).
6Department of Medical Endocrinology, Odense University Hospital, Odense, Denmark (P.H.).
7Institute of Clinical Research, University of Southern Denmark, and Department of Pathology, Odense University Hospital, Odense, Denmark (S.D.).
8Novo Nordisk Foundation, Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark (T.H.).
9Department of Gastroenterology and Hepatology, Odense University Hospital, and Institute of Clinical Research, University of Southern Denmark, Odense C, Denmark (A.K.).
Abstract
Background: It remains unclear if a low-carbohydrate, high-fat (LCHF) diet is a possible treatment strategy for type 2 diabetes mellitus (T2DM), and the effect on nonalcoholic fatty liver disease (NAFLD) has not been investigated.
Objective: To investigate the effect of a calorie-unrestricted LCHF diet, with no intention of weight loss, on T2DM and NAFLD compared with a high-carbohydrate, low-fat (HCLF) diet.
Design: 6-month randomized controlled trial with a 3-month follow-up. (ClinicalTrials.gov: NCT03068078).
Setting: Odense University Hospital in Denmark from November 2016 until June 2020.
Participants: 165 participants with T2DM.
Intervention: Two calorie-unrestricted diets: LCHF diet with 50 to 60 energy percent (E%) fat, less than 20E% carbohydrates, and 25E% to 30E% proteins and HCLF diet with 50E% to 60E% carbohydrates, 20E% to 30E% fats, and 20E% to 25E% proteins.
Measurements: Glycemic control, serum lipid levels, metabolic markers, and liver biopsies to assess NAFLD.
Results: The mean age was 56 years (SD, 10), and 58% were women. Compared with the HCLF diet, participants on the LCHF diet had greater improvements in hemoglobin A1c (mean difference in change, -6.1 mmol/mol [95% CI, -9.2 to -3.0 mmol/mol] or -0.59% [CI, -0.87% to -0.30%]) and lost more weight (mean difference in change, -3.8 kg [CI, -6.2 to -1.4 kg]). Both groups had higher high-density lipoprotein cholesterol and lower triglycerides at 6 months. Changes in low-density lipoprotein cholesterol were less favorable in the LCHF diet group than in the HCLF diet group (mean difference in change, 0.37 mmol/L [CI, 0.17 to 0.58 mmol/L] or 14.3 mg/dL [CI, 6.6 to 22.4 mg/dL]). No statistically significant between-group changes were detected in the assessment of NAFLD. Changes were not sustained at the 9-month follow-up.
Limitation: Open-label trial, self-reported adherence, unintended weight loss, and lack of adjustment for multiple comparisons.
Conclusion: Persons with T2DM on a 6-month, calorie-unrestricted, LCHF diet had greater clinically meaningful improvements in glycemic control and weight compared with those on an HCLF diet, but the changes were not sustained 3 months after intervention.