Effect of a lacto-vegetarian diet combined with 14-hour time-restricted eating on metabolic outcomes in women with Type 2 diabetes: a 24-week randomized controlled trial

Women with type 2 diabetes mellitus (T2DM) often require interventions that are culturally acceptable, practical, sustainable, and can be easily fit into their daily routine to manage their blood sugar levels. Although plant-based dietary patterns and time-restricted fasting have demonstrated metabolic benefits, limited evidence exists on their combined effects in Indian women with T2DM. This trial evaluated whether a lactovegetarian diet combined with 14-hour time-restricted eating improves glycemic and cardiometabolic outcomes compared with usual diabetes care. 96 women (25–60 years) with T2DM were enrolled in a 24-week, multicenter, randomized, open-label parallel-arm trial; 90 completed the study. The participants were divided into two groups: an intervention group following a structured lacto-vegetarian diet combined with 14-hour fasting, and control group receiving usual diabetes care. The diet contained 15–20% protein, 20–25% fat, and improved carbohydrate quality (50–55% from whole grains/high-fiber foods). Biochemical estimations and anthropometric measurements were taken at baseline and 24 weeks. The study employed an intention-to-treat analysis protocol, and the perceived benefits and safety of the intervention were reported. At 24 weeks, baseline-adjusted between-group comparisons showed significantly greater improvements in the intervention group compared with usual diabetes care. The intervention group had lower adjusted values for body weight, BMI, glycemic, and lipid profiles. The adjusted mean HbA1c was 6.53% in the intervention group compared with 7.65% in the control group, with an adjusted mean difference of −1.12% (95% CI: −1.35 to −0.89; p < 0.001). HOMA-IR was also significantly lower in the intervention group, with an adjusted mean difference of −1.84 (95% CI: −2.27 to −1.41; p < 0.001). Adverse events were mild and transient, while most participants reported improved energy, mood, weight loss, and overall health. A culturally adaptable lacto-vegetarian diet combined with a 14-hour time-restricted fasting regimen safely improves metabolic control and insulin sensitivity in women with Type 2 Diabetes, offering a practical, women-centric strategy that may be implementable within structured clinical nutrition services, although its staffing requirements, cost, and scalability require further evaluation. CTRI/2024/09/073262, Ethical Approval by Institutional Committee: SIU/IEC/781A