The effect of high-protein, low-carbohydrate diets in the treatment of type 2 diabetes: a 12 month randomised controlled trial.
Study Goal
The researchers aimed to determine whether high-protein diets are superior to high-carbohydrate diets for improving glycaemic control in individuals with type 2 diabetes.
Results Summary
Both high-protein and high-carbohydrate diets resulted in similar reductions in HbA(1c), weight, serum triacylglycerol, and total cholesterol, with no significant differences between groups. No superior long-term metabolic benefits of a high-protein diet were observed.
Population
Overweight/obese individuals (BMI 27-40 kg/m²) with type 2 diabetes (HbA(1c) 6.5-10%).
Effective Dosage
High-protein diet (30% total energy), high-carbohydrate diet (55% total energy).
Duration
12 months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
high-protein diet | increase | weight loss | people with type 2 diabetes | - | can enhance | #1 |
high-protein diet | increase | glycaemic control | people with type 2 diabetes | - | improve | #2 |
high-protein diet | no change | HbA(1c) | overweight/obese individuals with type 2 diabetes | 0.04 [95% CI -0.37, 0.46] | no significant difference | #3 |
high-protein diet | decrease | HbA(1c) | overweight/obese individuals with type 2 diabetes | - | decreased | #4 |
high-carbohydrate diet | decrease | HbA(1c) | overweight/obese individuals with type 2 diabetes | - | decreased | #5 |
high-protein diet | decrease | weight | overweight/obese individuals with type 2 diabetes | - | decreases | #6 |
high-carbohydrate diet | decrease | weight | overweight/obese individuals with type 2 diabetes | - | decreases | #7 |
high-protein diet | decrease | serum triacylglycerol | overweight/obese individuals with type 2 diabetes | - | decreases | #8 |
high-carbohydrate diet | decrease | serum triacylglycerol | overweight/obese individuals with type 2 diabetes | - | decreases | #9 |
high-protein diet | decrease | total cholesterol | overweight/obese individuals with type 2 diabetes | - | decreases | #10 |
high-carbohydrate diet | decrease | total cholesterol | overweight/obese individuals with type 2 diabetes | - | decreases | #11 |
high-protein diet | increase | HDL-cholesterol | overweight/obese individuals with type 2 diabetes | - | increases | #12 |
high-carbohydrate diet | increase | HDL-cholesterol | overweight/obese individuals with type 2 diabetes | - | increases | #13 |
high-protein diet | no change | blood pressure | overweight/obese individuals with type 2 diabetes | - | no differences | #14 |
high-carbohydrate diet | no change | blood pressure | overweight/obese individuals with type 2 diabetes | - | no differences | #15 |
high-protein diet | no change | renal function | overweight/obese individuals with type 2 diabetes | - | no differences | #16 |
high-carbohydrate diet | no change | renal function | overweight/obese individuals with type 2 diabetes | - | no differences | #17 |
high-protein diet | no change | calcium loss | overweight/obese individuals with type 2 diabetes | - | no differences | #18 |
high-carbohydrate diet | no change | calcium loss | overweight/obese individuals with type 2 diabetes | - | no differences | #19 |
AIMS/HYPOTHESIS: Short-term dietary studies suggest that high-protein diets can enhance weight loss and improve glycaemic control in people with type 2 diabetes. However, the long-term effects of such diets are unknown. The aim of this study was to determine whether high-protein diets are superior to high-carbohydrate diets for improving glycaemic control in individuals with type 2 diabetes. METHODS: Overweight/obese individuals (BMI 27-40 kg/m(2)) with type 2 diabetes (HbA(1c) 6.5-10%) were recruited for a 12 month, parallel design, dietary intervention trial conducted at a diabetes specialist clinic (Melbourne, VIC, Australia). Of the 108 initially randomised, 99 received advice to follow low-fat (30% total energy) diets that were either high in protein (30% total energy, n = 53) or high in carbohydrate (55% total energy, n = 46). Dietary assignment was done by a third party using computer-generated random numbers. The primary endpoint was change in HbA(1c). Secondary endpoints included changes in weight, lipids, blood pressure, renal function and calcium loss. Study endpoints were assessed blinded to the diet group, but the statistical analysis was performed unblinded. This study used an intention-to-treat model for all participants who received dietary advice. Follow-up visits were encouraged regardless of dietary adherence and last measurements were carried forward for study non-completers. RESULTS: Ninety-nine individuals were included in the analysis (53 in high protein group, 46 in high carbohydrate group). HbA(1c) decreased in both groups over time, with no significant difference between groups (mean difference of the change at 12 months; 0.04 [95% CI -0.37, 0.46]; p = 0.44). Both groups also demonstrated decreases over time in weight, serum triacylglycerol and total cholesterol, and increases in HDL-cholesterol. No differences in blood pressure, renal function or calcium loss were seen. CONCLUSIONS/INTERPRETATION: These results suggest that there is no superior long-term metabolic benefit of a high-protein diet over a high-carbohydrate in the management of type 2 diabetes. TRIAL REGISTRATION: ACTRN12605000063617 ( www.anzctr.org.au ). FUNDING: This study was funded by a nutritional research grant from Meat and Livestock Australia (MLA). J.E. Shaw is supported by NHMRC Fellowship 586623.