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OpenTrials
Completed

NCT Number: NCT02877186

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

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.

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Key information

Conditions

Obesity Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

commercially-available diet soda

Other

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.

Other names: seltzer

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 24, 2016
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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