ObesityNCT02877186
Effects of Non-nutritive Sweeteners on the Composition of the Gut Microbiome
A study testing commercially-available diet soda in people with Obesity and Diabetes, run by George Washington University.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- What is being tested?
- commercially-available diet soda
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Being tested
- commercially-available diet soda, carbonated water (control)
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
commercially-available diet sodaOther
Subjects are asked to consume diet soda three times daily for one week.
carbonated water (control)Other
Also called seltzer
Subjects are asked to consume carbonated water three times daily for one week.
| Study group | Role | What they receive |
|---|---|---|
| Diet Soda | Experimental | Consumption of diet soda three times daily for one week Receives: Other: commercially-available diet soda |
| Carbonated Water | Placebo comparator | Consumption of plain, unsweetened, carbonated water three times daily for one week Receives: Other: carbonated water (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startFeb 2015
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Sylvetsky (Meni), George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877186
- Sponsor's protocol ID
- 011512
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2016
- Last updated
- 20 Aug 2020
- Results posted
- No
Publications
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.
PubMed 37902107Sylvetsky 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.
PubMed 28228424
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-nutritive Sweeteners on the Composition of the Gut Microbiome
- ClinicalTrials.gov ID
- NCT02877186
- Acronym / sponsor ID
- 011512
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet Soda | Experimental | Other: commercially-available diet sodaConsumption of diet soda three times daily for one week |
| Carbonated Water | Placebo comparator | Other: carbonated water (control)Consumption of plain, unsweetened, carbonated water three times daily for one week |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| commercially-available diet sodaSubjects are asked to consume diet soda three times daily for one week. | Other | Diet Soda |
| carbonated water (control)Also: seltzerSubjects are asked to consume carbonated water three times daily for one week. | Other | Carbonated Water |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Derived from this study: PubMed 37902107Sylvetsky 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.
- Derived from this study: PubMed 28228424Sylvetsky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing commercially-available diet soda in people with Obesity and Diabetes, run by George Washington University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taxa abundance before and after one-week of three times daily diet soda consumption (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02877186, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020; AzTrials last refreshed its copy on 8 Nov 2026.