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
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: (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. PRIMARY FUNDING SOURCE: Novo Nordisk Foundation.
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Hypocaloric low-carbohydrate diets and low-fat diets appear to be similarly effective in reducing liver lipid content and related biomarkers in individuals with MASLD.
“Hypocaloric low-carbohydrate diets and low-fat diets appear to be similarly effective in reducing liver lipid content and related biomarkers. 289,290”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [290]
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- Authors
- Hansen, C. D., Gram-Kampmann, E.-M., Hansen, J. K., Hugger, M. B., Madsen, B. S., Jensen, J. M., Olesen, S., Torp, N., Rasmussen, D. N., Kjærgaard, M., Johansen, S., Lindvig, K. P., Andersen, P., Thorhauge, K. H., Brønd, J. C., Hermann, P., Beck-Nielsen, H., Detlefsen, S., Hansen, T., Højlund, K., Thiele, M. S., Israelsen, M., & Krag, A.
- Affiliations
- University of Southern Denmark (DK)
- Odense University Hospital (DK)
- Department of Medical Endocrinology, Odense University Hospital, Odense, Denmark (P.H.)
- Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark (E.M.G., H.B., K.H.)
- University of Copenhagen (DK)
- ORCID
- Hansen, Camilla Dalby
- Gram-Kampmann, Eva-Marie
- Hansen, Johanne Kragh
- Hugger, Mie Balle
- Madsen, Bjørn Stæhr
- Olesen, Sara
- Torp, Nikolaj
- Rasmussen, Ditlev Nytoft
- Kjærgaard, Maria
- Johansen, Stine
- Lindvig, Katrine Prier
- Andersen, Peter
- Thorhauge, Katrine Holtz
- Brønd, Jan Christian
- Hermann, Pernille
- Detlefsen, Sönke
- Hansen, Torben
- Højlund, Kurt
- Thiele, Maja Sofie
- Israelsen, Mads
- Krag, Aleksander
- Venue
- Annals of Internal Medicine
- Publisher
- American College of Physicians
- Published
- 2023-01
- Volume
- 176
- Issue
- 1
- Pages
- 10-21
- ISSN
- 0003-4819 (ISSN-L)
- 1539-3704
- OpenAlex
- W4311286960
- Cited by
- 110
- References
- 38
- Citations by year
- 2026: 20 · 2025: 37 · 2024: 37 · 2023: 16
- FWCI
- 13.93
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Annals of Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
- University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Diet and metabolism studies
- Health Sciences › Medicine › Physiology › Dietary Effects on Health
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- low-carbohydrate high-fat diet, type 2 diabetes, non-alcoholic fatty liver disease, high-carbohydrate low-fat diet, glycemic control, HbA1c, serum lipids, triglycerides, HDL cholesterol, LDL cholesterol, weight loss, liver biopsy, dietary intervention, metabolic biomarkers, liver fibrosis, steatosis
- MeSH terms
- Aged, Blood Glucose, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Cholesterol, HDL, Cholesterol, LDL, Male, Middle Aged, Weight Loss, Diet, Fat-Restricted, Diet, Carbohydrate-Restricted, Diet, High-Fat, Non-alcoholic Fatty Liver Disease
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