Microbiome and Non-caloric Sweeteners in Humans

NCT03708939 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-08-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Weizmann Institute of Science

    lead OTHER

Principal Investigators

  • Eran Elinav · Weizmann Institute of Science

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-19
Primary Completion
2020-08-01
Completion
2021-01-01

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03708939 on ClinicalTrials.gov