Effects of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of the Effect of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism

Conditions
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Impaired Glucose Tolerance

Intervention / Treatment
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* Dietary Supplement: Sucralose-Aspartame
* Dietary Supplement: Aspartame-Sucralose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sucralose-Aspartame<br>Generic name: sucralose or aspartame, Dosage form: powder, Duration:seven days. | Dietary Supplement: Sucralose-Aspartame<br>* Sucralose or aspartame<br>Dietary Supplement: Aspartame-Sucralose<br>* Aspartame or sucralose<br>|
| Experimental: Aspartame-Sucralose<br>Generic name: aspartame or sucralose, Dosage form: powder, Duration:seven days. | Dietary Supplement: Sucralose-Aspartame<br>* Sucralose or aspartame<br>Dietary Supplement: Aspartame-Sucralose<br>* Aspartame or sucralose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Blood Glucose | Fasting blood glucose level and 2-hour oral glucose tolerance test (OGTT). | 0-200 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin, glucagon,GIP & GLP-1 | glucose homeostasis | 4 times during the 12 weeks period | 
| Fecal Microbiome & short chain fatty acids measurements | to detect bacterial composition in feces and SCFA changes | 4 times during the 12 weeks period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Nutritive Sweeteners, Artificial Sweeteners, Glucose Metabolism, Microbiota, Dysbiosis