Assessment of the Effect of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Manitoba
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Fasting Blood Glucose
Study Overview
Brief Summary
The Objectives of this study is to determine the effect(s) of daily non-caloric artificial sweetener (NAS) consumption (sucralose or aspartame) on the composition of the bacteria and also to determine the changes in glucose metabolism.
Detailed Description
The trial will be 12 weeks randomized, cross-over and double blinded with 2 treatment intervention ( sucralose and aspartame) , there will be a run in period (4 weeks), then phase 1 treatment period for two weeks followed by four weeks washout period then phase 2 treatment period(2 weeks). Healthy, normglycemic (<5.6 mmol/L) males and females ( 17 total) of age 18-45 y with a body mass index (BMI) 20-25 kg/m2 will be recruited.
Each participants will be given the dose of sweetener aspartame or sucralose during the treatment phase in a double-blind procedure.
the participant will be asked to consume the sweetener in a mixed flavoured beverage during each visit in the treatment phase.
Blood and stool sample collection will take place before after the run-in period, and after the washout period, as well as after each two-week treatment period.
glucose measurement: Capillary blood will be collected during each visit by registered nurse. Blood will be collected at fasting and at 12,30,45,60,90 and 120 minutes after the participants drink a glucose drink (75g glucose) for Oral glucose tolerance test.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •BMI between 20-25 kg/m2
- •Fasting blood glucose (FBG) < 5.7 mmol/L
- •women with regular menstrual cycle.
Exclusion Criteria
- •probiotic or antibiotic use within 6 months prior to the start of the study
- •metabolic or gastrointestinal disorders (diabetes mellitus types 1 and 2, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease, phenylketonuria)
- •pregnant or lactating women
Arms & Interventions
Sucralose-Aspartame
Generic name: sucralose or aspartame, Dosage form: powder, Duration:seven days.
Intervention: Sucralose-Aspartame (Dietary Supplement)
Sucralose-Aspartame
Generic name: sucralose or aspartame, Dosage form: powder, Duration:seven days.
Intervention: Aspartame-Sucralose (Dietary Supplement)
Aspartame-Sucralose
Generic name: aspartame or sucralose, Dosage form: powder, Duration:seven days.
Intervention: Sucralose-Aspartame (Dietary Supplement)
Aspartame-Sucralose
Generic name: aspartame or sucralose, Dosage form: powder, Duration:seven days.
Intervention: Aspartame-Sucralose (Dietary Supplement)
Outcomes
Primary Outcomes
Fasting Blood Glucose
Time Frame: 0-200 mins
Fasting blood glucose level and 2-hour oral glucose tolerance test (OGTT).
Secondary Outcomes
- Insulin, glucagon,GIP & GLP-1(4 times during the 12 weeks period)
- Fecal Microbiome & short chain fatty acids measurements(4 times during the 12 weeks period)