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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877186
• Other study ID #: 011512
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: December 2019

Study information

• Verified date: August 2020
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Other:
• commercially-available diet soda
Subjects are asked to consume diet soda three times daily for one week.
• carbonated water (control)
Subjects are asked to consume carbonated water three times daily for one week.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one week