Sucralose, Stevia, Gut Microbiome and Glucose Metabolism

March 21, 2018 updated by: University of Minnesota
This study will determine the influence of two non-caloric sweeteners on glucose metabolism via the gut microbiome in adult men and women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will determine the influence of two non-caloric sweeteners on glucose metabolism via the gut microbiome in adult men and women aged 35-55 years.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • ECRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: Generally health adult men and women aged 35-55 years old -

Exclusion Criteria:Adults will not be eligible who have chronic disease (cancer, CHD, diabetes, chronic kidney disease); pregnant or breast feeding; menopausal; has a history of bariatric surgery; taking prednisone/steroids, taking medication for PCOS, or take medications that influence blood glucose.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Sucralose
Participants will be asked to consume 180 mg/day of sucralose (in the form of capsules which is equivalent to three 12-oz cans of diet soda) for 14 days. According to the FDA, a 150 lb. person may consume up to 340 mg/day of sucralose (or 5.5 12-oz cans of sucralose-sweetened diet soda).
Other: Sucralose
Sweetner
ACTIVE_COMPARATOR: Stevia
Participants will be asked to consume 180 mg/day of stevia (in the form of capsules which is equivalent to three 12-oz cans of diet soda) for 14 days. According to the FDA, a 150 lb. person may consume up to 800 mg/day of stevia (or about 12 cans of stevia-sweetened diet soda).
Other: Stevia
Sweetner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-hour glucose
Time Frame: 14 days
An oral glucose tolerance test will be administered before and after consuming assigned sweetener to determine change in 2-hour glucose
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiome
Time Frame: 14 days
Gut microbiota will be measured before and after consuming assigned sweetener to determine change in gut microbiota.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Lyn M Steffen, PhD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 3, 2017

Primary Completion (ACTUAL)

January 31, 2018

Study Completion (ACTUAL)

January 31, 2018

Study Registration Dates

First Submitted

June 10, 2016

First Submitted That Met QC Criteria

June 10, 2016

First Posted (ESTIMATE)

June 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1605M88288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual data will not be made available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Impaired Glucose Tolerance

Clinical Trials on Sucralose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe