Official websites use. Share sensitive information only on official, secure websites. Correspondence: john. Background: Health authorities are near universal in their recommendation to replace sugar-sweetened beverages SSBs with water. Non-nutritive sweetened beverages NSBs are not as widely recommended as a replacement strategy due to a lack of established benefits and concerns they may induce glucose intolerance through changes in the gut microbiome.
Blocked randomization was performed centrally by computer with allocation concealment. Outcome assessment was blinded; however, blinding of participants and trial personnel was not possible. The two primary outcomes are oral glucose tolerance incremental area under the curve and gut microbiota beta-diversity weighted UniFrac distance.
Secondary outcomes include related markers of adiposity and glucose and insulin regulation. Adherence was assessed by objective biomarkers of added sugars and non-nutritive sweeteners and self-report intake. Analyses will be according to the intention to treat principle. Baseline results: Recruitment began on 1 June , and the last participant completed the trial on 15 October We screened participants, of whom 80 were enrolled and randomized in the main trial and 32 of these were enrolled and randomized in the Ectopic Fat sub-study.
The participants were predominantly middle-aged mean age The average baseline SSB intake was 1. Conclusions: Baseline characteristics for both the main and Ectopic Fat sub-study meet our inclusion criteria and represent a group with overweight or obesity, with characteristics putting them at risk for type 2 diabetes.
Findings will be published in peer-reviewed open-access medical journals and provide high-level evidence to inform clinical practice guidelines and public health policy for the use NSBs in sugars reduction strategies. Trial registration: ClinicalTrials. Keywords: low- and no-calorie sweeteners, sweetening agents, sugar-sweetened beverages, water, randomized controlled trial, type 2 diabetes, gut microbiota, glycemia, glucose control, overweight. Sugar-sweetened beverages SSBs are the single largest contributor of added sugars in the diet [ 1 , 2 ].
