NCT03708939

Microbiome and Non-caloric Sweeteners in Humans

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Weizmann Institute of Science · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2017-02-19
• Primary completion: 2020-08-01
• Completion: 2021-01-01
• First posted: 2018-10-17
• Last updated: 2021-08-04

Locations

1 site across 1 country: Israel