Microbiome and Non-caloric Sweeteners in Humans

NCT ID: NCT03708939

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-19
• Study Completion Date: 2021-01-01

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.

Conditions

Glucose Intolerance; Glucose, Low Blood; Glucose, High Blood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

glucose

Group Type: EXPERIMENTAL

Glucose

Intervention Type: DIETARY_SUPPLEMENT

Daily consumption of 5g of glucose, for 14 days.

aspartame

Group Type: EXPERIMENTAL

Aspartame

Intervention Type: DIETARY_SUPPLEMENT

Daily consumption of six commercially available sachets containing aspartame and glucose as bulking agent (1g each sachet), for 14 days.

sucralose

Group Type: EXPERIMENTAL

Sucralose

Intervention Type: DIETARY_SUPPLEMENT

Daily consumption of six commercially available sachets containing sucralose and glucose as bulking agent (1g each sachet), for 14 days.

saccharin

Group Type: EXPERIMENTAL

Saccharin

Intervention Type: DIETARY_SUPPLEMENT

Daily consumption of six commercially available sachets containing saccharine and glucose as bulking agent (1g each sachet), for 14 days.

Stevia

Group Type: EXPERIMENTAL

Stevia

Intervention Type: DIETARY_SUPPLEMENT

Daily consumption of six commercially available sachets containing Stevia and glucose as bulking agent (1g each sachet), for 14 days.

No supplement control

Group Type: EXPERIMENTAL

No Supplement

Intervention Type: OTHER

Follow up without any dietary supplementation.

Interventions

Glucose

Daily consumption of 5g of glucose, for 14 days.

Intervention Type: DIETARY_SUPPLEMENT

Aspartame

Daily consumption of six commercially available sachets containing aspartame and glucose as bulking agent (1g each sachet), for 14 days.

Intervention Type: DIETARY_SUPPLEMENT

Sucralose

Daily consumption of six commercially available sachets containing sucralose and glucose as bulking agent (1g each sachet), for 14 days.

Intervention Type: DIETARY_SUPPLEMENT

Saccharin

Daily consumption of six commercially available sachets containing saccharine and glucose as bulking agent (1g each sachet), for 14 days.

Intervention Type: DIETARY_SUPPLEMENT

Stevia

Daily consumption of six commercially available sachets containing Stevia and glucose as bulking agent (1g each sachet), for 14 days.

Intervention Type: DIETARY_SUPPLEMENT

No Supplement

Follow up without any dietary supplementation.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Weizmann Institute of Science

OTHER

Sponsor Role: lead

Responsible Party

Eran Elinav

Prof. Eran Elinav

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eran Elinav

Role: PRINCIPAL_INVESTIGATOR

Weizmann Institute of Science

Locations

Weizmann Institute of Science

Rehovot, , Israel

Countries

Israel

Other Identifiers

170-2

Identifier Type: -

Identifier Source: org_study_id