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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02877186
Enrollment
22
Registered
2016-08-24
Start date
2015-02-28
Completion date
2019-12-31
Last updated
2020-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Obesity

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.

Interventions

OTHERcommercially-available diet soda

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

OTHERcarbonated water (control)

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

Sponsors

George Washington University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Taxa abundance before and after one-week of three times daily diet soda consumptionone week16S rRNA and metagenomics sequencing will be used to determine microbial composition of stool samples before and after the one week intervention.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026