Microbiome and Non-caloric Sweeteners in Humans

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

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.

Study Overview

• Status: Completed
• Conditions: Glucose Intolerance; Glucose, Low Blood; Glucose, High Blood
• Intervention / Treatment: Dietary supplement: Glucose; Dietary supplement: Aspartame; Dietary supplement: Sucralose; Dietary supplement: Saccharin; Dietary supplement: Stevia; Other: No Supplement

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Reẖovot, Israel
    • Weizmann Institute of Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Weizmann Institute of Science
• Investigators: Principal Investigator: Eran Elinav, Weizmann Institute of Science

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2017
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: October 14, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: 170-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No