Effects of Non-nutritive Sweeteners on the Composition of the Gut Microbiome

August 19, 2020 updated by: Allison Sylvetsky (Meni), George Washington University
This pilot study is being conducted to evaluate whether consumption of diet soda sweetened with sucralose and acesulfame-potassium leads to changes in the gut microbiota. Following a one week run-in period, healthy, young adults are randomized to consume either diet soda or carbonated water (control) three times per day for one week. Stool and urine samples are collected at baseline, following the run-in, and after the one-week intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults aged 18-35 years
  • Consume less than 1 food/beverage with non-nutritive sweeteners per month
  • Able and willing to consume diet soda three times daily for 1 week

Exclusion Criteria:

  • Recent diet or significant weight change
  • Antibiotic use in the past 3 months
  • Diarrhea in the past two weeks
  • Use of medications known to affect metabolism or weight
  • Weight < 50 kg (110 lbs.)
  • History of metabolic complications including high blood sugar, elevated cholesterol, or liver disease

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diet Soda
Consumption of diet soda three times daily for one week
Other: commercially-available diet soda
Subjects are asked to consume diet soda three times daily for one week.
Placebo Comparator: Carbonated Water
Consumption of plain, unsweetened, carbonated water three times daily for one week
Other: carbonated water (control)
Subjects are asked to consume carbonated water three times daily for one week.
Other Names:
  • seltzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Taxa abundance before and after one-week of three times daily diet soda consumption
Time Frame: one week
16S rRNA and metagenomics sequencing will be used to determine microbial composition of stool samples before and after the one week intervention.
one week

Collaborators and Investigators

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

Sponsor

George Washington University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

August 17, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (Estimate)

August 24, 2016

Study Record Updates

Last Update Posted (Actual)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 011512

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.

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