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. The STOP Sugars NOW trial aims to assess the effect of the substitution of NSBs (the “intended substitution”) versus water (the “standard of care substitution”) for SSBs on glucose tolerance and microbiota diversity. Design and Methods: The STOP Sugars NOW trial (NCT03543644) is a pragmatic, “head-to-head”, open-label, crossover, randomized controlled trial conducted in an outpatient setting. Participants were overweight or obese adults with a high waist circumference who regularly consumed ≥1 SSBs daily. Each participant completed three 4-week treatment phases (usual SSBs, matched NSBs, or water) in random order, which were separated by ≥4-week washout. 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. A subset of participants was included in an Ectopic Fat sub-study in which the primary outcome is intrahepatocellular lipid (IHCL) by 1H-MRS. Analyses will be according to the intention to treat principle. Baseline results: Recruitment began on 1 June 2018, and the last participant completed the trial on 15 October 2020. We screened 1086 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 41.8 ± SD 13.0 y) and had obesity (BMI of 33.7 ± 6.8 kg/m2) with a near equal ratio of female: male (51%:49%). The average baseline SSB intake was 1.9 servings/day. SSBs were replaced with matched NSB brands, sweetened with either a blend of aspartame and acesulfame-potassium (95%) or sucralose (5%). 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.gov identifier, NCT03543644

Introduction: Inflammatory bowel disease (IBD), characterized by chronic intestinal inflammation, can be subcategorized into Crohns disease and ulcerative colitis. The treatment for these conditions is unique to each patient, and may include lifestyle changes, pharmaceutical intervention, and surgery. Lifestyle changes, such as dietary intervention, are a cornerstone of IBD symptom management. Given the daily burden of this disease, self-management is paramount in coping with and/or minimizing symptoms. The MyHealthyGut application (app), successfully proven to be a self-management tool for celiac disease, shows promise for use in an IBD patient population. Objective: To undertake user testing to inform the development of an IBD-focused version of the current MyHealthyGut app. Methods: This study was undertaken between October 2021 and April 2022. Participants included IBD patients and healthcare practitioners (HCPs) (physicians, registered dietitians [RD], and registered nurses [RN]), using social media postings and convenience sampling. Two RDs demonstrated how to use the current functions and features of the app with each participant. Participants used the app for a 2-week period which was followed by participation in a focus group or individual interview to provide feedback on the app. Qualitative questionnaires, tailored to each patient category, were administered verbally and feedback was recorded. Thematic analysis techniques were used for data quantification and analysis. Results: 15 participants were recruited and enrolled. Of these, 14 participants took part in the focus group and/or individual interviews. The feedback suggested changes related to clinical uses (e.g. incorporating information collected by the app into electronic medical record systems), food and symptom tracking (e.g. the option to track water intake), ease of use (e.g. the option to autofill food tracker with frequently consumed meals), and app content (e.g. information about IBD treatments). All (100%) of participants reported that they would either use the app themselves or recommend the app to patients, once their suggestions were implemented. Conclusion: Through user testing and feedback collection, priorities for app modification were identified. Areas of modification in the app functions and features, ease of use, and content were identified. Once updated to meet the needs of IBD patients, the MyHealthyGut app may be a useful tool for IBD self-management.

Objectives Health authorities recommend reducing added or free sugars to ≤5–10% energy. Much attention has focussed of the reduction of SSBs with the recommendation that SSBs be replaced with unsweetened healthy alternatives such as water but not non-nutritive sweetened beverages (NSBs). There are concerns that non-nutritive sweeteners do not have the intended benefits and may induce glucose intolerance through changes in the gut microbiome. Whether NSBs have benefits similar to water in their intended substitution for SSBs is unclear. Methods To address this question, we have undertaken the STOP Sugars NOW trial (NCT03543644), a pragmatic “head-to-head” crossover randomized controlled trial of the effect of NSBs (the intended substitution) versus water (the standard of care) as a replacement strategy for SSBs on glucose tolerance and gut microbiome diversity. We recruited overweight or obese participants with a high waist circumference who regularly consume ≥1 SSBs/day. Each participant underwent a ≥2-week run-in period followed by three 4- week treatment phases in random order (usual SSBs, equivalent NSBs, or water) with each phase separated by a ≥4-week washout. The two primary outcomes are change in glucose tolerance and gut microbiome beta- diversity. Adherence to the interventions will be assessed by objective biomarkers of added sugars (13C/12C isotopic ratio in serum fatty acids and urinary fructose and sucrose) and non-nutritive sweeteners (urinary sucralose and acesulfame-potassium). Results The trial started on June 1st, 2018 with the first participant undergoing randomization on August 1st, 2019 and the last participant finishing on October 15th, 2020. We screened 1,086 individuals, out of which 80 were randomized. Baseline characteristics showed a mean age of 41.8 ± 13.0 y, BMI of 33.7 ± 6.8 kg/m2, waist circumference of 108.7 ± 13.5 cm, and mean SSBs intake of 2 SSBs/day. Conclusions The results of this trial will directly inform public health guidance on the use of NSBs in sugars reduction strategies. Funding Sources CIHR.