Microbiome and Non-caloric Sweeteners in Humans
Primary Purpose
Glucose Intolerance, Glucose, Low Blood, Glucose, High Blood
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Glucose
Aspartame
Sucralose
Saccharin
Stevia
No Supplement
Sponsored by

About this trial
This is an interventional basic science trial for Glucose Intolerance
Eligibility Criteria
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.
Sites / Locations
- Weizmann Institute of Science
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
glucose
aspartame
sucralose
saccharin
Stevia
No supplement control
Arm Description
Outcomes
Primary Outcome Measures
Blood glucose level
Continuous glucose monitor device
Secondary Outcome Measures
Microbiome
Stool and oral samples
Full Information
NCT ID
NCT03708939
First Posted
October 14, 2018
Last Updated
August 3, 2021
Sponsor
Weizmann Institute of Science
1. Study Identification
Unique Protocol Identification Number
NCT03708939
Brief Title
Microbiome and Non-caloric Sweeteners in Humans
Official Title
The Role of the Microbiome in Personalized Human Response to Non-caloric Sweeteners
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 19, 2017 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Weizmann Institute of Science
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance, Glucose, Low Blood, Glucose, High Blood
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
glucose
Arm Type
Experimental
Arm Title
aspartame
Arm Type
Experimental
Arm Title
sucralose
Arm Type
Experimental
Arm Title
saccharin
Arm Type
Experimental
Arm Title
Stevia
Arm Type
Experimental
Arm Title
No supplement control
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose
Intervention Description
Daily consumption of 5g of glucose, for 14 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Aspartame
Intervention Description
Daily consumption of six commercially available sachets containing aspartame and glucose as bulking agent (1g each sachet), for 14 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Sucralose
Intervention Description
Daily consumption of six commercially available sachets containing sucralose and glucose as bulking agent (1g each sachet), for 14 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Saccharin
Intervention Description
Daily consumption of six commercially available sachets containing saccharine and glucose as bulking agent (1g each sachet), for 14 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Stevia
Intervention Description
Daily consumption of six commercially available sachets containing Stevia and glucose as bulking agent (1g each sachet), for 14 days.
Intervention Type
Other
Intervention Name(s)
No Supplement
Intervention Description
Follow up without any dietary supplementation.
Primary Outcome Measure Information:
Title
Blood glucose level
Description
Continuous glucose monitor device
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Microbiome
Description
Stool and oral samples
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eran Elinav
Organizational Affiliation
Weizmann Institute of Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weizmann Institute of Science
City
Reẖovot
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Microbiome and Non-caloric Sweeteners in Humans
We'll reach out to this number within 24 hrs