At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Controlled Trial of the Effect of Replacing Sugar-sweetened Beverages With Non-nutritive Sweetened Beverages or Water on Gut Microbiome and Metabolic Outcomes: STOP Sugars NOW Trial
In Brief
A clinical study evaluating Sugar-sweetened beverage (SSB), Non-nutritive sweetened beverages (NSB), and 1 other intervention for Healthy and 10 related conditions. Completed, enrolled 81 participants across 1 site.
Detailed Summary
Health authorities recommend a reduction in added sugars from sugar-sweetened beverages (SSBs) due to risk of obesity and diabetes. As a sugar-reduction strategy, finding the ideal SSB replacement is of the utmost importance. Those who are already consuming SSBs might not easily replace it with water and therefore non-nutritive sweetened beverages (NSBs) present a sweetened alternative, though guidelines recommend water instead of NSBs as a replacement for SSBs. Recent evidence suggests that saccharine, a non-nutritive sweetener, which is not found in NSBs, might induce glucose intolerance by altering gut microbiota in humans. It is currently not known if replacing SSBs with NSBs (which contain low-calorie sweeteners other than saccharine) or water will have any effect on the human gut microbiota and any downstream diabetic risk. The investigators plan to undertake a randomized controlled cross-over trial in 75 healthy adults to assess the effect of replacing SSBs with equal amounts of NSBs or water for 4 weeks on the composition and diversity of human gut microbiota, changes in glucose tolerance and total body fat in those who regularly drink SSBs. Each participant will act as their own control receiving each of the three interventions of SSB, NSB and water for four weeks in random order, each period separated by a four-week wash-out period. All study visits will occur at the Clinical Nutrition and Risk Factor Modification Centre at St. Michael's Hospital. This study will contribute to knowledge that will inform dietary guidelines and public policy with regards to the best possible replacement for SSBs. It will also shed light on the potential mechanism of the adverse effects of NSBs and if the replacement of SSBs by NSBs or water are in fact similar with respect to their effect on gut bacteria and any downstream diabetic risk.
Study Details
Timeline
Interventions
SSBs will be provided to each participant. Participants will be able to choose their SSB of choice from the list in the protocol. They will be instructed to drink their usual SSB intake, study drinks provided, while freely consume their usual background diets. They will revert to their usual SSB intake during wash-out phase during which they will not receive any beverage drinks from the study.
NSBs will be provided to each participant. Participants will be be given the NSB equivalent to the usual SSB chosen from the list in the protocol. They will be instructed to replace their usual SSBs with the NSBs while freely consume their usual background diets. They will revert to their usual SSB intake during wash-out phase during which they will not receive any beverage drinks from the study.
Water will be provided to each participant. They will be instructed to replace their usual SSBs with the water while freely consume their usual background diets. They will revert to their usual SSB intake during wash-out phase during which they will not receive any beverage drinks from the study.