Microbiome and Non-caloric Sweeteners in Humans

Not Applicable

Completed

• Conditions: Glucose, High Blood; Glucose, Low Blood; Glucose Intolerance
• Interventions: Dietary Supplement: Sucralose; Dietary Supplement: Glucose; Dietary Supplement: Aspartame; Dietary Supplement: Saccharin; Dietary Supplement: Stevia; Other: No Supplement

• Registration Number: NCT03708939
• Lead Sponsor: Weizmann Institute of Science

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-19
• Study First Submitted: 2018-10-14
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-17
• Primary Completion: 2020-08-01
• Study Completion: 2021-01-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. BMI<28
2. Age - 18-70
3. Capable of working with smartphone application
4. Capable to work with a glucometer

Exclusion Criteria

1. Consumption of antibitioics 3 months prior to the first day of the experiment.
2. Consumption of Non caloric sweetners 6 months prior to the first day of the experiment.
3. Diagnosis with type 1 or type 2 diabetes.
4. Pregnancy, fertility treatments
5. Breastfeeding (Including baby to breast and bottle feeding expressed breast milk)
6. Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism etc.)
7. Cancer and recent anticancer treatment
8. Psychiatric disorders
9. Coagulation disorders
10. IBD (inflammatory bowel diseases)
11. Bariatric surgery
12. Alcohol or substance abuse
13. BMI>28
14. Aspartame group only: phenylketonuria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sucralose	Sucralose	-
glucose	Glucose	-
aspartame	Aspartame	-
saccharin	Saccharin	-
Stevia	Stevia	-
No supplement control	No Supplement	-

Primary Outcome Measures

Name	Time	Method
Blood glucose level	28 days	Continuous glucose monitor device

Secondary Outcome Measures

Name	Time	Method
Microbiome	28 days	Stool and oral samples

Trial Locations

Locations (1)

Weizmann Institute of Science; 🇮🇱 Reẖovot, Israel