Microbiome and Non-caloric Sweeteners in Humans
NCT03708939 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2021-08-04
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.
Conditions
- Glucose Intolerance
- Glucose, Low Blood
- Glucose, High Blood
Interventions
- DIETARY_SUPPLEMENT
-
Glucose
Daily consumption of 5g of glucose, for 14 days.
- DIETARY_SUPPLEMENT
-
Aspartame
Daily consumption of six commercially available sachets containing aspartame and glucose as bulking agent (1g each sachet), for 14 days.
- DIETARY_SUPPLEMENT
-
Sucralose
Daily consumption of six commercially available sachets containing sucralose and glucose as bulking agent (1g each sachet), for 14 days.
- DIETARY_SUPPLEMENT
-
Saccharin
Daily consumption of six commercially available sachets containing saccharine and glucose as bulking agent (1g each sachet), for 14 days.
- DIETARY_SUPPLEMENT
-
Stevia
Daily consumption of six commercially available sachets containing Stevia and glucose as bulking agent (1g each sachet), for 14 days.
- OTHER
-
No Supplement
Follow up without any dietary supplementation.
Sponsors & Collaborators
-
Weizmann Institute of Science
lead OTHER
Principal Investigators
-
Eran Elinav · Weizmann Institute of Science
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-02-19
- Primary Completion
- 2020-08-01
- Completion
- 2021-01-01
Countries
- Israel
Study Locations
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