Glucose Intolerance, Glucose, Low Blood, Glucose, High Blood
Conditions
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.
Interventions
DIETARY_SUPPLEMENTGlucose
Daily consumption of 5g of glucose, for 14 days.
DIETARY_SUPPLEMENTAspartame
Daily consumption of six commercially available sachets containing aspartame and glucose as bulking agent (1g each sachet), for 14 days.
DIETARY_SUPPLEMENTSucralose
Daily consumption of six commercially available sachets containing sucralose and glucose as bulking agent (1g each sachet), for 14 days.
DIETARY_SUPPLEMENTSaccharin
Daily consumption of six commercially available sachets containing saccharine and glucose as bulking agent (1g each sachet), for 14 days.
DIETARY_SUPPLEMENTStevia
Daily consumption of six commercially available sachets containing Stevia and glucose as bulking agent (1g each sachet), for 14 days.
OTHERNo Supplement
Follow up without any dietary supplementation.
Sponsors
Weizmann Institute of Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose level | 28 days | Continuous glucose monitor device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiome | 28 days | Stool and oral samples |
Countries
Israel
Outcome results
None listed