Development and Pragmatic Randomized Controlled Trial of Healthy Ketogenic Diet Versus Energy-Restricted Diet on Weight Loss in Adults with Obesity.
Study Goal
The researchers aimed to compare the effects of a Healthy Ketogenic Diet (HKD) versus an Energy-Restricted Diet (ERD) on weight loss and metabolic outcomes in adults with obesity.
Results Summary
The HKD group showed significantly greater weight loss and better improvements in metabolic profiles (glycated hemoglobin, systolic blood pressure, and aspartate transaminase) compared to the ERD group, without increasing LDL-cholesterol levels.
Population
Multi-ethnic Asian adults with a BMI ≥ 27.5 kg/m².
Effective Dosage
Net carbohydrate intake limited to ≤50 g per day for the HKD group.
Duration
6 months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Healthy Ketogenic Diet (HKD) | decrease | weight | Multi-ethnic Asian adults with body mass index ≥ 27.5 kg/m2 | -7.8 ± 5.2 kg vs. -4.2 ± 5.6 kg | achieved significantly greater mean weight loss at 6 months than the ERD group | #1 |
Healthy Ketogenic Diet (HKD) | decrease | weight | Multi-ethnic Asian adults with body mass index ≥ 27.5 kg/m2 | 9.3 ± 5.9% vs. 4.9 ± 5.8% | mean weight loss percentage at 6 months was | #2 |
Healthy Ketogenic Diet (HKD) | decrease | glycated hemoglobin | Multi-ethnic Asian adults with body mass index ≥ 27.5 kg/m2 | -0.3 ± 0.3% vs. -0.1 ± 0.2% | Improvements in metabolic profiles were also significantly better | #3 |
Healthy Ketogenic Diet (HKD) | decrease | systolic blood pressure | Multi-ethnic Asian adults with body mass index ≥ 27.5 kg/m2 | -7.7 ± 8.9 mmHg vs. -2.6 ± 12.2 mmHg | Improvements in metabolic profiles were also significantly better | #4 |
Healthy Ketogenic Diet (HKD) | decrease | aspartate transaminase | Multi-ethnic Asian adults with body mass index ≥ 27.5 kg/m2 | -7.6 ± 15.5 IU/L vs. 0.6 ± 11.5 IU/L | Improvements in metabolic profiles were also significantly better | #5 |
Healthy Ketogenic Diet (HKD) | no change | LDL-cholesterol | Multi-ethnic Asian adults with body mass index ≥ 27.5 kg/m2 | -0.12 ± 0.60 mmol/L vs. -0.04 ± 0.56 mmol/L | with no increase in LDL-cholesterol | #6 |
Energy-Restricted Diet (ERD) | no change | LDL-cholesterol | Multi-ethnic Asian adults with body mass index ≥ 27.5 kg/m2 | -0.12 ± 0.60 mmol/L vs. -0.04 ± 0.56 mmol/L | with no increase in LDL-cholesterol | #7 |
Introduction: The ketogenic diet (KD) is widely used for weight management by reducing appetite, enhancing fat oxidation, and facilitating weight loss. However, the high content of total and saturated fats in a conventional KD may elevate low-density lipoprotein (LDL)-cholesterol levels, a known risk factor for cardiovascular diseases, highlighting the need for healthier alternatives. This study aimed to investigate the effect of a newly developed Healthy Ketogenic Diet (HKD) versus an Energy-Restricted Diet (ERD) on weight loss and metabolic outcomes among adults with obesity. Methods: Multi-ethnic Asian adults (n = 80) with body mass index ≥ 27.5 kg/m2 were randomized either to HKD (n = 41) or ERD (n = 39) for 6 months. Both groups followed an energy-restricted healthy diet, emphasizing on reducing saturated and trans fats. The HKD group additionally limited net carbohydrate intake to no more than 50 g per day. Dietary adherence was supported via the Nutritionist Buddy app with dietitian coaching. The primary outcome was weight change from baseline at 6 months. Secondary outcomes included weight change at 3 months and 1 year, along with changes in metabolic profiles. Data were analyzed using linear regression with an intention-to-treat approach. Results: The HKD group achieved significantly greater mean weight loss at 6 months than the ERD group (-7.8 ± 5.2 kg vs. -4.2 ± 5.6 kg, p = 0.01). The mean weight loss percentage at 6 months was 9.3 ± 5.9% and 4.9 ± 5.8% for the HKD and ERD groups, respectively (p = 0.004). Improvements in metabolic profiles were also significantly better in the HKD group [glycated hemoglobin (-0.3 ± 0.3% vs. -0.1 ± 0.2%, p = 0.008), systolic blood pressure (-7.7 ± 8.9 mmHg vs. -2.6 ± 12.2 mmHg, p = 0.005), and aspartate transaminase (-7.6 ± 15.5 IU/L vs. 0.6 ± 11.5 IU/L, p = 0.01)], with no increase in LDL-cholesterol (-0.12 ± 0.60 mmol/L vs. -0.04 ± 0.56 mmol/L, p = 0.97) observed in either group. Conclusions: The HKD was more effective than the ERD in promoting weight loss and improving cardiometabolic outcomes without elevation in LDL-cholesterol. It can be recommended for therapeutic intervention in patients with obesity.