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Microbiome and Non-caloric Sweeteners in Humans

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ClinicalTrials.gov Identifier: NCT03708939
Recruitment Status : Completed
First Posted : October 17, 2018
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
Eran Elinav, 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.

Condition or disease Intervention/treatment Phase
Glucose Intolerance Glucose, Low Blood Glucose, High Blood Dietary Supplement: Glucose Dietary Supplement: Aspartame Dietary Supplement: Sucralose Dietary Supplement: Saccharin Dietary Supplement: Stevia Other: No Supplement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Role of the Microbiome in Personalized Human Response to Non-caloric Sweeteners
Actual Study Start Date : February 19, 2017
Actual Primary Completion Date : August 1, 2020
Actual Study Completion Date : January 1, 2021

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.




Primary Outcome Measures :
  1. Blood glucose level [ Time Frame: 28 days ]
    Continuous glucose monitor device


Secondary Outcome Measures :
  1. Microbiome [ Time Frame: 28 days ]
    Stool and oral samples



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708939


Locations
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Israel
Weizmann Institute of Science
Reẖovot, Israel
Sponsors and Collaborators
Weizmann Institute of Science
Investigators
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Principal Investigator: Eran Elinav Weizmann Institute of Science
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Responsible Party: Eran Elinav, Prof. Eran Elinav, Weizmann Institute of Science
ClinicalTrials.gov Identifier: NCT03708939    
Other Study ID Numbers: 170-2
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases