NCT03708939

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

August 4, 2021

Status Verified

August 1, 2021

Enrollment Period

3.4 years

First QC Date

October 14, 2018

Last Update Submit

August 3, 2021

Conditions

Glucose IntoleranceGlucose, Low BloodGlucose, High Blood

Outcome Measures

Primary Outcomes (1)

  • Blood glucose level

    Continuous glucose monitor device

    28 days

Secondary Outcomes (1)

  • Microbiome

    28 days

Study Arms (6)

glucose

EXPERIMENTAL
Dietary Supplement: Glucose

aspartame

EXPERIMENTAL
Dietary Supplement: Aspartame

sucralose

EXPERIMENTAL
Dietary Supplement: Sucralose

saccharin

EXPERIMENTAL
Dietary Supplement: Saccharin

Stevia

EXPERIMENTAL
Dietary Supplement: Stevia

No supplement control

EXPERIMENTAL
Other: No Supplement

Interventions

GlucoseDIETARY_SUPPLEMENT

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

glucose
AspartameDIETARY_SUPPLEMENT

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

aspartame
SucraloseDIETARY_SUPPLEMENT

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

sucralose
SaccharinDIETARY_SUPPLEMENT

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

saccharin
SteviaDIETARY_SUPPLEMENT

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

Stevia
No SupplementOTHER

Follow up without any dietary supplementation.

No supplement control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI\<28
  • Age - 18-70
  • Capable of working with smartphone application
  • Capable to work with a glucometer

You may not qualify if:

  • Consumption of antibitioics 3 months prior to the first day of the experiment.
  • Consumption of Non caloric sweetners 6 months prior to the first day of the experiment.
  • Diagnosis with type 1 or type 2 diabetes.
  • Pregnancy, fertility treatments
  • Breastfeeding (Including baby to breast and bottle feeding expressed breast milk)
  • Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism etc.)
  • Cancer and recent anticancer treatment
  • Psychiatric disorders
  • Coagulation disorders
  • IBD (inflammatory bowel diseases)
  • Bariatric surgery
  • Alcohol or substance abuse
  • BMI\>28
  • Aspartame group only: phenylketonuria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weizmann Institute of Science

Rehovot, Israel

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

GlucoseAspartametrichlorosucroseSaccharinstevioside

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesDipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsThiazolesSulfur CompoundsOrganic ChemicalsBenzothiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Eran Elinav

    Weizmann Institute of Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Eran Elinav

Study Record Dates

First Submitted

October 14, 2018

First Posted

October 17, 2018

Study Start

February 19, 2017

Primary Completion

August 1, 2020

Study Completion

January 1, 2021

Last Updated

August 4, 2021

Record last verified: 2021-08

Locations

IL(1)