Impaired Glucose Tolerance
Conditions
Keywords
Non-Nutritive Sweeteners, Artificial Sweeteners, Glucose Metabolism, Microbiota, Dysbiosis
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. a food frequency questionnaire will be given to each participant in order to estimate how often each sweetener is consumed on a daily basis. Participants will also be asked to complete weekly food diaries of food and drink consumption.
Interventions
DIETARY_SUPPLEMENTSucralose-Aspartame
Sucralose or aspartame
DIETARY_SUPPLEMENTAspartame-Sucralose
Aspartame or sucralose
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Blood Glucose | 0-200 mins | Fasting blood glucose level and 2-hour oral glucose tolerance test (OGTT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin, glucagon,GIP & GLP-1 | 4 times during the 12 weeks period | glucose homeostasis |
| Fecal Microbiome & short chain fatty acids measurements | 4 times during the 12 weeks period | to detect bacterial composition in feces and SCFA changes |
Countries
Canada
Outcome results
None listed