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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2019-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Obesity Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Diet Soda

Consumption of diet soda three times daily for one week

Group Type EXPERIMENTAL

commercially-available diet soda

Intervention Type OTHER

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

Carbonated Water

Consumption of plain, unsweetened, carbonated water three times daily for one week

Group Type PLACEBO_COMPARATOR

carbonated water (control)

Intervention Type OTHER

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

Interventions

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commercially-available diet soda

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

Intervention Type OTHER

carbonated water (control)

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

Intervention Type OTHER

Other Intervention Names

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seltzer

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes