NCT02877186

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

4.8 years

First QC Date

August 17, 2016

Last Update Submit

August 19, 2020

Conditions

ObesityDiabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Diet Soda

EXPERIMENTAL

Consumption of diet soda three times daily for one week

Other: commercially-available diet soda

Carbonated Water

PLACEBO COMPARATOR

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

Other: carbonated water (control)

Interventions

commercially-available diet sodaOTHER

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

Diet Soda
carbonated water (control)OTHER

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

Also known as: seltzer
Carbonated Water

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Sylvetsky AC, Clement RA, Stearrett N, Issa NT, Dore FJ, Mazumder R, King CH, Hubal MJ, Walter PJ, Cai H, Sen S, Rother KI, Crandall KA. Consumption of sucralose- and acesulfame-potassium-containing diet soda alters the relative abundance of microbial taxa at the species level: findings of two pilot studies. Appl Physiol Nutr Metab. 2024 Jan 1;49(1):125-134. doi: 10.1139/apnm-2022-0471. Epub 2023 Oct 30.

    PMID: 37902107DERIVED

  • Sylvetsky AC, Walter PJ, Garraffo HM, Robien K, Rother KI. Widespread sucralose exposure in a randomized clinical trial in healthy young adults. Am J Clin Nutr. 2017 Apr;105(4):820-823. doi: 10.3945/ajcn.116.144402. Epub 2017 Feb 22.

    PMID: 28228424DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Interventions

Carbonated Water

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Mineral WatersWaterHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsCarbonated BeveragesBeveragesDiet, Food, and NutritionPhysiological PhenomenaDrinking WaterFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 24, 2016

Study Start

February 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

August 20, 2020

Record last verified: 2020-08