This trial is active, not recruiting.

Conditions obesity, diabetes
Treatments commercially-available diet soda, carbonated water (control)
Sponsor George Washington University
Start date February 2015
End date December 2016
Trial size 22 participants
Trial identifier NCT02877186, 011512


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Consumption of diet soda three times daily for one week
commercially-available diet soda
Subjects are asked to consume diet soda three times daily for one week.
(Placebo Comparator)
Consumption of plain, unsweetened, carbonated water three times daily for one week
carbonated water (control) seltzer
Subjects are asked to consume carbonated water three times daily for one week.

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 35 years old.

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

Additional Information

Official title Effects of Non-nutritive Sweeteners on the Composition of the Gut Microbiome
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by George Washington University.