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

Not Applicable

Completed

• Conditions: Obesity; Diabetes
• Interventions: Other: commercially-available diet soda; Other: carbonated water (control)

• Registration Number: NCT02877186
• Lead Sponsor: George Washington University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-19
• Study First Posted: 2016-08-24
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-19
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet Soda	commercially-available diet soda	Consumption of diet soda three times daily for one week
Carbonated Water	carbonated water (control)	Consumption of plain, unsweetened, carbonated water three times daily for one week

Primary Outcome Measures

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