Microbiome and Non-caloric Sweeteners in Humans

Weizmann Institute of Science

Status: Completed

Conditions: Glucose, High Blood; Glucose Intolerance; Glucose, Low Blood

Treatments: Dietary Supplement: Glucose; Dietary Supplement: Saccharin; Other: No Supplement; Dietary Supplement: Aspartame; Dietary Supplement: Stevia; Dietary Supplement: Sucralose

Study type: Interventional

Funder types: Other

Identifiers

NCT03708939

170-2

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 6 patient groups

glucose

Experimental group

Treatment:

Dietary Supplement: Glucose

aspartame

Experimental group

Treatment:

Dietary Supplement: Aspartame

sucralose

Experimental group

Treatment:

Dietary Supplement: Sucralose

saccharin

Experimental group

Treatment:

Dietary Supplement: Saccharin

Stevia

Experimental group

Treatment:

Dietary Supplement: Stevia

No supplement control

Experimental group

Treatment:

Other: No Supplement