Efficacy of a diabetes-specific formula used as a meal replacement in the management of type 2 diabetes: a randomized controlled trial

Abstract Background Type 2 diabetes mellitus (T2DM) is a major and growing health burden in Asia, where maintaining glycemic control remains challenging because of high refined carbohydrate consumption and rapid dietary transitions. Evidence from randomized controlled trials evaluating culturally adapted low–glycemic index (GI) diabetes-specific formulas (DSFs) in Asian outpatient settings remains limited. This study evaluated the effect of a low-GI DSF (GI 26; D-care) used as a once-daily meal replacement on glycemic control and metabolic parameters in Thai adults with T2DM. Methods A total of 102 adults with T2DM (aged 35–75 years) were randomly assigned to a control group receiving standard nutrition advice (CT, n = 51) or an intervention group receiving standard nutrition advice plus one daily DSF meal replacement (DC, n = 51) for 90 days. Outcomes were analyzed using linear mixed-effects models to assess time, group, and time × group interaction effects. Results Compared with the CT group, the DC group showed a significantly greater reduction in HbA1c (adjusted mean difference − 0.34%, 95% CI − 0.6 to − 0.1; p = 0.020). Reductions in fasting blood glucose, triglycerides, body weight, and daily energy intake were observed in the DC group; however, these changes were not significantly different between groups. Conclusion Once-daily use of a low-GI diabetes-specific formula as part of standard nutritional counseling was associated with improved glycemic control in Thai adults with T2DM. This strategy may represent a practical dietary approach for diabetes management in Asian populations. Trial registration Thai Clinical Trials Registry (TCTR20230122001), registered on 22 January 2023.