Microbiome and Non-caloric Sweeteners in Humans

Glucose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03708939
• Other study ID #: 170-2
• Status: Completed
• Phase: N/A
• Start date: February 19, 2017
• Est. completion date: January 1, 2021

Study information

• Verified date: August 2021
• Source: Weizmann Institute of Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Glucose, High Blood
• Glucose, Low Blood
• Hyperglycemia
• Hypoglycemia

Intervention

Dietary Supplement:
• Glucose
Daily consumption of 5g of glucose, for 14 days.
• Aspartame
Daily consumption of six commercially available sachets containing aspartame and glucose as bulking agent (1g each sachet), for 14 days.
• Sucralose
Daily consumption of six commercially available sachets containing sucralose and glucose as bulking agent (1g each sachet), for 14 days.
• Saccharin
Daily consumption of six commercially available sachets containing saccharine and glucose as bulking agent (1g each sachet), for 14 days.
• 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.

Locations

Country	Name	City	State
Israel	Weizmann Institute of Science	Re?ovot

Sponsors (1)

Lead Sponsor	Collaborator
Weizmann Institute of Science

Country where clinical trial is conducted

Israel, 

Outcome

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