Healthy Clinical Trial
Official title:
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
Verified date | April 2021 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 81 |
Est. completion date | October 15, 2020 |
Est. primary completion date | October 15, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Healthy, adult (age, 18-75 years) men and non-pregnant women; - Overweight or obese (BMI > 23 kg/m2 for Asian individuals and > 25 kg/m2 other individuals); - High waist circumference (> 94 cm in men, > 80 cm in women in Europid, Sub-Saharan African, Eastern Mediterranean, and Middle Eastern individuals; > 90 cm in men and > 80 cm in women for South Asian, Chinese, Japanese, and South and Central American individuals); - Currently report drinking SSBs regularly (= 1 serving daily); - Have a primary care physician; - Nonsmoker; - Free of any diseases or illnesses; - Not regularly taking any medications that have a clinically relevant effect on the primary outcomes, as deemed inappropriate by investigators Exclusion Criteria: - Age < 18 or > 75 years; - BMI < 23 kg/m2 for Asian individuals and < 25 kg/m2 other individuals; - Waist circumference < 94cm in men, < 80cm in women in Europid, Sub-Saharan African, Eastern Mediterranean, and Middle Eastern individuals; < 90cm in men and < 80 cm in women for South Asian, Chinese, Japanese, and South and Central American individuals; - Not regularly drinking SSBs (=1 serving per day); - Pregnant or breast feeding females, or women planning on becoming pregnant throughout study duration; - Regular medication use that have a clinically relevant effect on the primary outcomes, as deemed inappropriate by investigators - Antibiotic use in the last 3 months; - Complementary or alternative medicine (CAM) use as deemed inappropriate by investigators; - Self-reported diabetes; - Self-reported uncontrolled hypertension (or systolic blood pressure (BP) = 160 mmHg or diastolic BP = 100 mmHg [26]); - Self-reported polycystic ovarian syndrome; - Self-reported cardiovascular disease; - Self-reported gastrointestinal disease; - Previous bariatric surgery; - Self-reported liver disease; - Self-reported uncontrolled hyperthyroidism or hypothyroidism; - Self-reported kidney disease; - Self-reported chronic infection; - Self-reported lung disease; - Self-reported cancer/malignancy; - Self-reported schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, and dissociative disorders; - Major surgery in the last 6 months; - Other major illness or health-related incidence within the last 6 months; - Smoker; - Regular recreational drug users; - Heavy alcohol use (> 3 drinks/day); - Do not have a primary care physician; - Participation in any trials within the last 6 months or for the duration of this study; - Individuals planning on making dietary or physical activity changes throughout study duration; - If participating in MRI portion of study: any condition or circumstance which would prevent the participant from having an MRI (e.g. having prostheses or metal implants, tattoos, or claustrophobia) |
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto | Canadian Institutes of Health Research (CIHR) |
Canada,
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* Note: There are 55 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Ectopic fat in liver (intra-hepatocellular lipid [IHCL]) by 1H-MRS (sub-study, n=30) | Week 0 and week 4 of each intervention | ||
Other | Ectopic fat in calf muscles (intra-myocellular lipid [IMCL]) by 1H-MRS (sub-study, n=30) | Week 0 and week 4 of each intervention | ||
Other | Fasting plasma insulin | Week 0 and week 4 of each intervention | ||
Other | 75g OGTT derived iAUC plasma insulin | Week 0 and week 4 of each intervention | ||
Other | 75g OGTT derived maximum concentrations (Cmax) and time to maximum concentrations (Tmax) of plasma glucose | Week 0 and week 4 of each intervention | ||
Other | 75g OGTT derived maximum concentrations (Cmax) and time to maximum concentrations (Tmax) of plasma insulin | Week 0 and week 4 of each intervention | ||
Other | 75g OGTT derived mean incremental plasma glucose | Week 0 and week 4 of each intervention | ||
Other | 75g OGTT derived mean incremental plasma insulin | Week 0 and week 4 of each intervention | ||
Other | Homeostatic model assessment of insulin resistance (HOMA IR) | Week 0 and week 4 of each intervention | ||
Other | Insulin secretion-sensitivity index-2 (ISSI-2) | Week 0 and week 4 of each intervention | ||
Other | Satiety, hunger, and food cravings (using the Control of Eating Questionnaire) | Week 0 and week 4 of each intervention | ||
Other | Diet quality by Alternative Healthy Eating Index (AHEI) (using a weighed three-day diet record) | Week 0 and week 4 of each intervention | ||
Other | Adherence markers - Objective biomarkers of SSBs (increased 13C/12C ratios in serum fatty acids and increased urinary fructose) | Week 0 and week 4 of each intervention | ||
Other | Adherence markers - Objective biomarkers water (decreased 13C/12C ratios in serum fatty acids and decreased urinary fructose) | Week 0 and week 4 of each intervention | ||
Other | Adherence markers - Objective biomarkers NSBs (increased urinary acesulfame potassium and/or sucralose) | Week 0 and week 4 of each intervention | ||
Other | Adherence markers - Beverage logs | Week 0 and week 4 of each intervention | ||
Other | Adherence markers - Returned unused bottles | Week 0 and week 4 of each intervention | ||
Other | Cardiometabolic risk - change in systolic blood pressure | Week 0 and week 4 of each intervention | ||
Other | Cardiometabolic risk - change in diastolic blood pressure | Week 0 and week 4 of each intervention | ||
Other | Cardiometabolic risk - Lipid profile - LDL Cholesterol | Week 0 and week 4 of each intervention | ||
Other | Cardiometabolic risk - Lipid profile - HDL Cholesterol | Week 0 and week 4 of each intervention | ||
Other | Cardiometabolic risk - Lipid profile - non-HDL Cholesterol | Week 0 and week 4 of each intervention | ||
Other | Cardiometabolic risk - Lipid profile - Total Cholesterol | Week 0 and week 4 of each intervention | ||
Other | Cardiometabolic risk - Lipid profile - Triglycerides | Week 0 and week 4 of each intervention | ||
Other | Cardiometabolic risk - C-Reactive Protein (CRP) | Week 0 and week 4 of each intervention | ||
Other | Cardiometabolic risk - urinary sodium | Week 0 and week 4 of each intervention | ||
Other | Cardiometabolic risk - Liver function/injury by ALT | Week 0 and week 4 of each intervention | ||
Other | Cardiometabolic risk - Liver function/injury by AST | Week 0 and week 4 of each intervention | ||
Other | Cardiometabolic risk - Liver function/injury by ALP | Week 0 and week 4 of each intervention | ||
Other | Cardiometabolic risk - Liver function/injury by TBIL | Week 0 and week 4 of each intervention | ||
Other | Cardiometabolic risk - Kidney function/injury by creatinine | Week 0 and week 4 of each intervention | ||
Other | Cardiometabolic risk - Kidney function/injury by eGFR | Week 0 and week 4 of each intervention | ||
Other | Cardiometabolic risk - Kidney function/injury by urinary ACR | Week 0 and week 4 of each intervention | ||
Other | Urinary and blood metabolomic panel | Week 0 and week 4 of each intervention | ||
Other | Urinary and blood proteomic panel | Week 0 and week 4 of each intervention | ||
Primary | Gut microbiome composition measured by 16S rRNA gene sequencing | Week 0 and week 4 of each intervention | ||
Primary | 75g OGTT derived plasma glucose iAUC | Week 0 and week 4 of each intervention | ||
Secondary | Change in waist circumference | Week 0 and week 4 of each intervention | ||
Secondary | Change in body weight | Week 0 and week 4 of each intervention | ||
Secondary | Change in fasting plasma glucose | Week 0 and week 4 of each intervention | ||
Secondary | 75g OGTT derived 2-hour plasma glucose [2h-PG] | Week 0 and week 4 of each intervention | ||
Secondary | 75g OGTT derived Matsuda whole body insulin sensitivity index [Matsuda ISI OGTT] | Week 0 and week 4 of each intervention |
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