The Effect of Substituting Water for Artificially Sweetened Beverages on Glycemic and Weight Measures in People With Type 2 Diabetes: The Study of Drinks With Artificial Sweeteners (SODAS), a Randomized Trial.

OBJECTIVE: To test the effect of substituting plain water (the ideal standard) for habitual artificial sweetened beverage (ASB) intake by people with type 2 diabetes (T2D) on primary measures of diabetes control. RESEARCH DESIGN AND METHODS: The Study of Drinks with Artificial Sweeteners in People with T2D (SODAS) was conducted at two academic health centers and was a randomized, two-arm, parallel trial with a 2-week run-in period and a 24-week active intervention period. Adults with T2D (n = 181; HbA1c 6.5-8.5%; aged ≥35 years) who regularly consumed commercial ASBs were randomized to receive and consume 24 oz daily for 24 weeks of either 1) a commercial ASB of choice (control) or 2) an unflavored, sparkling or still, bottled or canned water of choice in place of ASBs. The outcomes measures were collected at baseline, 12, and 24 weeks and included the primary measure (HbA1c) and related secondary measures (fructosamine, fasting glucose and insulin, body weight, and continuous glucose monitor metrics). RESULTS: A total of 179 participants provided complete data over 24 weeks. From baseline to 24 weeks, the mean difference in change of HbA1c was 0.29% (SE 0.12; P = 0.013) higher in the water arm compared with the ASB arm. There were no significant effects on secondary clinical measures, but data were directionally consistent with the primary results. CONCLUSIONS: For people with T2D and HbA1c <8.5% who regularly consume ASBs, this trial provided no evidence that substituting water would improve glycemic-related clinical care measures over 24 weeks.