Microbiome and Non-caloric Sweeteners in Humans

Study Overview
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Brief Summary
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Non-caloric sweeteners are common food supplements consumed by millions worldwide as means of combating weight gain and diabetes, by retaining sweet taste without increasing caloric intake. While they are considered safe, there is increasing debate regarding their potential role in contributing to metabolic derangements in some humans. The investigators recently demonstrated that non-caloric sweeteners consumption could induce glucose intolerance in mice and, in preliminary experiments, in distinct human subsets, by functionally altering the gut microbiome, and that the gut microbiome plays an important role in mediating differential glucose responses to identical foods. The proportion of the human population that is susceptible to glucose intolerance induced by non-caloric sweeteners, the common factors that are shared between these individuals and whether and how the microbiome promotes the metabolic derangements remain to be addressed.

Official Title
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The Role of the Microbiome in Personalized Human Response to Non-caloric Sweeteners

Conditions
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Glucose Intolerance, Glucose, Low Blood, Glucose, High Blood

Intervention / Treatment
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* Dietary Supplement: Glucose
* Dietary Supplement: Aspartame
* Dietary Supplement: Sucralose
* Dietary Supplement: Saccharin
* Dietary Supplement: Stevia
* Other: No Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI<28 Age - 18-70 Capable of working with smartphone application Capable to work with a glucometer Exclusion Criteria: Consumption of antibitioics 3 months prior to the first day of the experiment. Consumption of Non caloric sweetners 6 months prior to the first day of the experiment. Diagnosis with type 1 or type 2 diabetes. Pregnancy, fertility treatments Breastfeeding (Including baby to breast and bottle feeding expressed breast milk) Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism etc.) Cancer and recent anticancer treatment Psychiatric disorders Coagulation disorders IBD (inflammatory bowel diseases) Bariatric surgery Alcohol or substance abuse BMI>28 Aspartame group only: phenylketonuria.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glucose<br> | Dietary Supplement: Glucose<br>* Daily consumption of 5g of glucose, for 14 days.<br>|
| Experimental: aspartame<br> | Dietary Supplement: Aspartame<br>* Daily consumption of six commercially available sachets containing aspartame and glucose as bulking agent (1g each sachet), for 14 days.<br>|
| Experimental: sucralose<br> | Dietary Supplement: Sucralose<br>* Daily consumption of six commercially available sachets containing sucralose and glucose as bulking agent (1g each sachet), for 14 days.<br>|
| Experimental: saccharin<br> | Dietary Supplement: Saccharin<br>* Daily consumption of six commercially available sachets containing saccharine and glucose as bulking agent (1g each sachet), for 14 days.<br>|
| Experimental: Stevia<br> | Dietary Supplement: Stevia<br>* Daily consumption of six commercially available sachets containing Stevia and glucose as bulking agent (1g each sachet), for 14 days.<br>|
| Experimental: No supplement control<br> | Other: No Supplement<br>* Follow up without any dietary supplementation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose level | Continuous glucose monitor device | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome | Stool and oral samples | 28 days |