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
Hansen CD, Gram-Kampmann EM, Hansen JK, Hugger MB, Madsen BS, Jensen JM, Olesen S, Torp N, Rasmussen DN, Kjærgaard M, Johansen S, Lindvig KP, Andersen P, Thorhauge KH, Brønd JC, Hermann P, Beck-Nielsen H, Detlefsen S, Hansen T, Højlund K, Thiele MS, Israelsen M, Krag A
Annals of internal medicine · 90 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
- Consumo medido con
- No se indica
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Steno Diabetes Center Odense (SDCO)
- Universidad u hospital
- NNF Center for Basic Metabolic Research
Según 2 financiadores declarados.
Publicación
- Publicado
- 2022-12-12 · Ann Intern Med · vol. 176 · número 1 · págs. 10–21
- Editorial
- American College of Physicians
- Citado
- 108 citas · más que el 99% de estudios similares · 11.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 38 trabajos
- Acceso
- De pago
- Áreas de investigación
- Diet and metabolism studies · Dietary Effects on Health · Diabetes Management and Research
- Palabras clave
- 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
- humans, diabetes mellitus, type 2, weight loss, blood glucose, diet, fat-restricted, aged, middle aged, female, male, diet, carbohydrate-restricted, cholesterol, ldl, cholesterol, hdl, diet, high-fat, non-alcoholic fatty liver disease, glycated hemoglobin
23 autores
- Camilla Dalby Hansen🇩🇰University of Southern Denmark; Odense University Hospital
- Eva-Marie Gram-Kampmann🇩🇰Odense University Hospital
- Johanne Kragh Hansen🇩🇰Odense University Hospital
- Mie Balle Hugger🇩🇰University of Southern Denmark; Odense University Hospital
- Bjørn Stæhr Madsen🇩🇰Odense University Hospital
- Jane Møller Jensen🇩🇰Odense University Hospital
- Sara Olesen🇩🇰Odense University Hospital
- Nikolaj Torp🇩🇰University of Southern Denmark; Odense University Hospital
- Ditlev Nytoft Rasmussen🇩🇰Odense University Hospital
- Maria Kjærgaard🇩🇰University of Southern Denmark; Odense University Hospital
- Stine Johansen🇩🇰University of Southern Denmark; Odense University Hospital
- Katrine Prier Lindvig🇩🇰University of Southern Denmark; Odense University Hospital
- Peter Andersen🇩🇰Odense University Hospital
- Katrine Holtz Thorhauge🇩🇰University of Southern Denmark; Odense University Hospital
- Jan Christian Brønd🇩🇰University of Southern Denmark
- Anne Pernille Hermann🇩🇰Odense University Hospital
- Henning Beck‐Nielsen🇩🇰Odense University Hospital
- Sönke Detlefsen🇩🇰University of Southern Denmark; Odense University Hospital
- Torben F. Hansen🇩🇰University of Copenhagen; Novo Nordisk Foundation Center for Basic Metabolic Research
- Kurt Højlund🇩🇰Odense University Hospital
- Maja Sofie Thiele🇩🇰University of Southern Denmark; Odense University Hospital
- Mads Egerod Israelsen🇩🇰Odense University Hospital
- Aleksander Ahm Krag🇩🇰University of Southern Denmark; Odense University Hospital
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Primary funding source
Novo Nordisk Foundation.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
Confianza de la comunidad
Cargando…
¿Cuánto confías en los hallazgos de este estudio?
Comentarios
¿Algo está mal aquí?
Señala este estudio si su información, etiquetas o financiación parecen incorrectas. Un editor revisa cada señalamiento.
Información educativa sobre investigación publicada. No es consejo médico ni una recomendación para empezar o dejar nada.