Effect of Replacing Sucrose in Beverages with Nonnutritive Sweetener Sucralose on Cardiometabolic Risk Factors Among Asian Indian Adults with Type 2 Diabetes: A 12-Week Randomized Controlled Trial.

Introduction: Country-specific evidence-based research is crucial for understanding the role of nonnutritive sweeteners (NNS) in managing type 2 diabetes (T2D). The main aim of this study was to explore the effect of replacing sucrose with sucralose in coffee/tea in Asian Indians with type 2 diabetes (T2D).

Methods: This 12-week, parallel-arm randomized controlled trial included 210 participants with T2D, assigned to the intervention group, where sugar/sucrose in coffee or tea was substituted with sucralose, or the control group, where sugar/sucrose was continued. Lifestyle factors remained unchanged. The primary outcome was change in HbA1c. Secondary outcomes were changes in body weight (BW), body mass index (BMI), waist circumference (WC), lipid profiles, and inflammatory markers.

Results: At the end of 12 weeks, no change was observed in HbA1c, fasting plasma glucose, lipid profile, and inflammatory markers between or within groups. There was a small but significant reduction in BW (- 0.5 kg [95% CI - 1.0, - 0.1]; p = 0.02), BMI (- 0.2 kg/m² [- 0.4, 0.0]; p = 0.03), and WC (- 0.8 cm [- 1.4, - 0.3]; p = 0.002) in the intervention group. Improvements were also observed in lipid accumulation product (p = 0.01), visceral adiposity index (p = 0.04), triglyceride/glucose index (p = 0.04), total energy intake (p = 0.04), and carbohydrate intake (p < 0.0001).

Conclusions: In Asian Indians with T2D, replacing about 60 kcal of added sucrose with sucralose in coffee/ tea had no benefit on glycemia but resulted in a small reduction in body weight, body mass index, and waist circumference.

Trial registration: Clinical Trials Registry of India (CTRI/2021/04/032686).