Glucose Intolerance Clinical Trial
Official title:
The Role of the Microbiome in Personalized Human Response to Non-caloric Sweeteners
NCT number | NCT03708939 |
Other study ID # | 170-2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 19, 2017 |
Est. completion date | January 1, 2021 |
Verified date | August 2021 |
Source | Weizmann Institute of Science |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | January 1, 2021 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Israel | Weizmann Institute of Science | Re?ovot |
Lead Sponsor | Collaborator |
---|---|
Weizmann Institute of Science |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood glucose level | Continuous glucose monitor device | 28 days | |
Secondary | Microbiome | Stool and oral samples | 28 days |
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