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
Authors' 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.
Study context
- Population
- Adults with T2D, Odense University Hospital, Denmark, 2016–2020; mean age 56 years (SD 10), 58% women
- Participants
- 165 adults
- Comparison
- Calorie-unrestricted low-carbohydrate, high-fat (LCHF) diet vs high-carbohydrate, low-fat (HCLF) diet
Methodological detailsopen-label, 6-month intervention with 3-month follow-up, single-centre, Limitations: open-label, self-reported adherence, unintended weight loss, no adjustment for multiple comparisons
- Open-label
- 6-month intervention with 3-month follow-up
- Single-centre
- Limitations: open-label, self-reported adherence, unintended weight loss, no adjustment for multiple comparisons
Primary result
As reported in the abstract
Change in HbA1c · 6 months
Each group vs HCLFMean difference in change, mmol/mol (95% CI)
LCHF
−6.1(−9.2 to −3.0)
Each group vs HCLFMean difference in change, % (95% CI)
LCHF
−0.59(−0.87% to −0.30%)
Further findings
| Outcome | Mean difference in change (kg) (CI) | |
|---|---|---|
| Change in weight · 6 monthsMore weight lost with LCHF | −3.8 (−6.2 to −1.4) | |
| −10−505Difference, kg (linear scale) |
| Outcome | Mean difference in change (mmol/L) (CI) | |
|---|---|---|
| Change in LDL-C · 6 monthsLCHFvs HCLFLess favourable with LCHF | 0.37 (0.17–0.58) | |
| −0.500.51Difference, mmol/L (linear scale) |
| Outcome | Mean difference in change (mg/dL) (CI) | |
|---|---|---|
| Change in LDL-C · 6 monthsLCHFvs HCLFLess favourable with LCHF | 14.3 (6.6–22.4) | |
| −100102030Difference, mg/dL (linear scale) |
HDL-C and TG · 6 months
- Both groups had higher HDL-C and lower TG at 6 months
Nonalcoholic fatty liver disease (NAFLD) (liver biopsy)
- No statistically significant between-group changes in NAFLD
Sustainability · 9-month follow-up
- Changes were not sustained at the 9-month follow-up
Original publication
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. Published 13 December 2022. doi:10.
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