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

George Washington University22 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Obesity Diabetes

Interventions

commercially-available diet sodaOTHER

Subjects are asked to consume diet soda three times daily for one week.

carbonated water (control)OTHER

Subjects are asked to consume carbonated water three times daily for one week.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Taxa abundance before and after one-week of three times daily diet soda consumption

16S rRNA and metagenomics sequencing will be used to determine microbial composition of stool samples before and after the one week intervention.

Time frame: one week

Data from ClinicalTrials.gov

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