A 5:2 Intermittent Fasting Meal Replacement Diet and Glycemic Control for Adults With Diabetes: The EARLY Randomized Clinical Trial.
AI Summary
This randomized clinical trial examined whether a 5:2 intermittent fasting approach with meal replacements could benefit adults with early type 2 diabetes. The EARLY study followed 405 Chinese participants (mean age 45.5 years, BMI 29.5) for 16 weeks, comparing the 5:2 meal replacement diet against standard diabetes medications metformin and empagliflozin. The 5:2 approach involved two nonconsecutive fasting days with meal replacements and five days of normal eating per week. Results showed the intermittent fasting group achieved superior outcomes in both blood sugar control and weight loss compared to medication alone. While promising for diabetes management, this study was conducted specifically in Chinese adults with early-stage diabetes over a relatively short timeframe. The findings suggest intermittent fasting with structured meal replacements may serve as an effective initial intervention for newly diagnosed type 2 diabetes, though longer-term studies would help establish sustained benefits.
Key Findings
- The 5:2 intermittent fasting group achieved greater HbA1c reduction (-1.9%) compared to metformin (-1.6%) and empagliflozin (-1.5%) over 16 weeks
- Weight loss was significantly greater in the 5:2 group (-9.7 kg) versus metformin (-5.5 kg) and empagliflozin (-5.8 kg) groups
- The study included 405 Chinese adults with early type 2 diabetes, mean age 45.5 years and BMI 29.5
Abstract
An intermittent fasting plan consisting of 2 nonconsecutive fasting days and 5 days of habitual intake per week and meal replacement diet (5:2 MR) could provide additional benefits to patients with type 2 diabetes. To evaluate the effect of the 5:2 MR on glycemic control among patients with early type 2 diabetes compared with metformin and empagliflozin. The EARLY (Exploration of Treatment of Newly Diagnosed Overweight/Obese Type 2 Diabetes Mellitus) study is a randomized, open-label, active parallel-controlled clinical trial conducted between November 13, 2020, and December 29, 2022, in 9 centers across China. A total of 509 eligible patients underwent screening, out of which 405 were randomly assigned to 3 groups and included in the intention-to-treat analysis. Patients were randomly allocated in a 1:1:1 ratio to receive either metformin, empagliflozin, or 5:2 MR. The treatment was 16 weeks, with an 8-week follow-up. The primary end point was the change in hemoglobin A1c (HbA1c) level from baseline to 16 weeks. Secondary end points included changes in body weight, anthropometric measurements, and biochemical parameters. Of the 405 randomized participants (265 men [65.4%]; mean [SD] age, 45.5 [11.0] years; mean [SD] body mass index, 29.5 [4.1]; and mean [SD] HbA1c level, 7.9% [0.6%]), 332 completed the 16-week treatment. From baseline to week 16, participants in the 5:2 MR group showed the greatest reduction in HbA1c (least-squares mean [LSM], -1.9% [SE, 0.2%]), significantly greater than patients receiving metformin (LSM, -1.6% [SE, 0.2%]; adjusted LSM difference, -0.3% [95% CI, -0.4% to -0.1%]) and empagliflozin (LSM, -1.5% [SE, 0.2%]; adjusted LSM difference, -0.4% [95% CI, -0.6% to -0.2%]). At week 16, the mean weight loss in the 5:2 MR group (LSM, -9.7 kg [SE, 2.2 kg]) was greater than that in the metformin group (LSM, -5.5 kg [SE, 2.3 kg]) and empagliflozin group (LSM, -5.8 kg [SE, 2.3 kg]). This randomized clinical trial of Chinese adults with overweight or obesity and with early type 2 diabetes found that 5:2 MR could improve glycemic outcomes and weight loss in the short term compared with metformin or empagliflozin, making it a promising initial intervention and early management for type 2 diabetes. Chinese Clinical Trial Registry Identifier: ChiCTR2000040656.
Authors
Lixin Guo, Yue Xi, Wenbo Jin, Huijuan Yuan, Guijun Qin, Shuchun Chen, Lihui Zhang, Yu Liu, Xingbo Cheng, Wen Liu, Dongni Yu