PrediabetesNCT07868432
Glycemic Impact of NNS Via the Gut Microbiome
A study testing Sucralose in people with Prediabetes, run by Tufts University at 1 site in United States.
Trial summary
This pilot study will evaluate the feasibility and acceptability of a 30-day sucralose intervention among adults with prediabetes. Participants will consume six commercial sucralose (Splenda®) packets daily for 30 days while wearing a blinded continuous glucose monitor (CGM). Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Prediabetes
- What is being tested?
- Sucralose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1c measured within the past 6 months between 5.7% and 6.4%.
- eGFR measured within the past 6 months of at least 45 mL/min/1.73 m².
- Prediabetes defined by diagnosis code R73.0 or a subcategory.
- Age 35 years or older.
- BMI of at least 25 kg/m².
- Low non-nutritive sweetener use, defined as less than once per week.
Who cannot join
- Type 1 diabetes.
- Type 2 diabetes.
- History of bariatric surgery.
- History of organ or tissue transplantation.
- Current GLP-1 agonist treatment.
- Current metformin treatment.
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- Current oral steroid medication.
- Current immunosuppressant use, including tacrolimus, cyclosporine, mycophenolate mofetil, prednisone, methylprednisolone, sirolimus, or everolimus.
- Severe gastrointestinal disease, at the discretion of the PI and physician Co-Investigator.
- Severe comorbidities with poor physical or mental function that may prevent completion of study procedures, at the discretion of the PI and physician Co-Investigator.
- Current or planned pregnancy or lactation.
- Self-reported non-nutritive sweetener allergy or intolerance.
- Regular consumption of non-nutritive sweetener products, defined as once per week or more often.
- Concurrent participation in another study involving dietary changes, investigational drugs, or microbiome-altering agents.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Non-Nutritive Sweeteners, Glucose Homeostasis, and the Gut Microbiome in Prediabetes
This pilot study will evaluate the feasibility and acceptability of a 30-day sucralose intervention among adults with prediabetes. Participants will consume six commercial sucralose (Splenda®) packets daily for 30 days while wearing a blinded continuous glucose monitor (CGM). Oral glucose tolerance tests (OGTTs) with blood draws will be performed at baseline and after 30 days to assess glucose incremental area under the curve (iAUC). Stool samples will also be collected to assess the feasibility of microbiome sample collection for future studies. The study will generate preliminary data to inform the design of a larger randomized clinical trial examining the effects of non-nutritive sweeteners on glucose homeostasis and the gut microbiome.
Read the detailed description
This is a prospective, single-arm pilot trial enrolling 10 adults with prediabetes. Participants will undergo baseline and post-intervention OGTTs with blood draws, wear blinded Dexcom G7 Pro continuous glucose monitors throughout the 30-day study period, complete dietary and physical activity recalls, and provide stool samples at baseline and post-intervention. Participants will consume six Splenda® packets daily, providing 72 mg sucralose per day, for 30 days.
The primary objectives are to:
- Assess study feasibility and acceptability, including recruitment, retention, intervention adherence, completion of study procedures, and biospecimen collection.
- Generate preliminary data on changes in glucose incremental area under the curve during an oral glucose tolerance test.
- Conditions
- Prediabetes
- Being tested
- Sucralose
- Keywords
- Prediabetes, sucralose, non-nutritive sweeteners, continuous glucose monitoring, gut microbiome, oral glucose tolerance test
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucraloseDietary supplement
Sucralose (Splenda®): six commercial tabletop packets daily, totaling 72 mg sucralose per day, for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Sucralose Intervention | Experimental | Participants will consume six Splenda® packets daily for 30 days. Receives: Dietary Supplement: Sucralose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
Number and proportions of participants reached, eligible, agreeing to participate, and enrolled, plus time required to enroll 10 participants.
Measured: Enrollment period
Change in OGTT glucose iAUC
Change in glucose incremental area under the curve during oral glucose tolerance testing from baseline to Day 30.
Measured: Baseline and Day 30
Retention feasibility
Percentage of enrolled participants who attend the post-intervention visit.
Measured: Day 30
Intervention adherence
Percentage of daily consumption surveys completed, percentage of assigned packets consumed by self-report, and agreement with packet counts.
Measured: Days 1-30
OGTT acceptability
Frequency of IV line failure or venous intolerance and intolerance of the OGTT beverage.
Measured: Baseline and Day 30
CGM acceptability
Completion of 30-day CGM wear, sensor failures, and percentage of possible glucose data points captured.
Measured: Days 1-30
Diet and activity recall acceptability
Time needed to complete each 24-hour dietary and physical activity recall.
Measured: Baseline and Day 30
Stool collection acceptability
Percentage of participants who complete both planned stool sample collections.
Measured: Baseline through Day 30
Secondary outcomes (2)
Time in range
Percentage of CGM readings with glucose below 140 mg/dL.
Measured: Days 1-30
Glycemic variability
Coefficient of variation calculated from CGM data.
Measured: Days 1-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts Medical Center
- Responsible party
- Principal investigator, Meng Wang, Tufts University
- Investigators
- Meng Wang, Principal investigator, Food is Medicine Institute, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868432
- Sponsor's protocol ID
- STUDY00007045
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Nutritive Sweeteners, Glucose Homeostasis, and the Gut Microbiome in Prediabetes
- ClinicalTrials.gov ID
- NCT07868432
- Acronym / sponsor ID
- STUDY00007045
- Conditions
- Prediabetes
- Keywords
- Prediabetes, sucralose, non-nutritive sweeteners, continuous glucose monitoring, gut microbiome, oral glucose tolerance test
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Tufts Medical Center
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Oct 2026 (actual)
- 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 will evaluate the feasibility and acceptability of a 30-day sucralose intervention among adults with prediabetes. Participants will consume six commercial sucralose (Splenda®) packets daily for 30 days while wearing a blinded continuous glucose monitor (CGM). Oral glucose tolerance tests (OGTTs) with blood draws will be performed at baseline and after 30 days to assess glucose incremental area under the curve (iAUC). Stool samples will also be collected to assess the feasibility of microbiome sample collection for future studies. The study will generate preliminary data to inform the design of a larger randomized clinical trial examining the effects of non-nutritive sweeteners on glucose homeostasis and the gut microbiome.
Detailed description
This is a prospective, single-arm pilot trial enrolling 10 adults with prediabetes. Participants will undergo baseline and post-intervention OGTTs with blood draws, wear blinded Dexcom G7 Pro continuous glucose monitors throughout the 30-day study period, complete dietary and physical activity recalls, and provide stool samples at baseline and post-intervention. Participants will consume six Splenda® packets daily, providing 72 mg sucralose per day, for 30 days.
The primary objectives are to:
- Assess study feasibility and acceptability, including recruitment, retention, intervention adherence, completion of study procedures, and biospecimen collection.
- Generate preliminary data on changes in glucose incremental area under the curve during an oral glucose tolerance test.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sucralose Intervention | Experimental | Dietary Supplement: SucraloseParticipants will consume six Splenda® packets daily for 30 days. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HbA1c measured within the past 6 months between 5.7% and 6.4%.
- eGFR measured within the past 6 months of at least 45 mL/min/1.73 m².
- Prediabetes defined by diagnosis code R73.0 or a subcategory.
- Age 35 years or older.
- BMI of at least 25 kg/m².
Key exclusion criteria (14 listed)
- Type 1 diabetes.
- Type 2 diabetes.
- History of bariatric surgery.
- History of organ or tissue transplantation.
- Current GLP-1 agonist treatment.
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 |
|---|---|---|
| SucraloseSucralose (Splenda®): six commercial tabletop packets daily, totaling 72 mg sucralose per day, for 30 days. | Dietary supplement | Sucralose Intervention |
Primary outcome
Recruitment feasibility
Time frame: Enrollment period
Number and proportions of participants reached, eligible, agreeing to participate, and enrolled, plus time required to enroll 10 participants.
Change in OGTT glucose iAUC
Time frame: Baseline and Day 30
Change in glucose incremental area under the curve during oral glucose tolerance testing from baseline to Day 30.
Retention feasibility
Time frame: Day 30
Percentage of enrolled participants who attend the post-intervention visit.
Intervention adherence
Time frame: Days 1-30
Percentage of daily consumption surveys completed, percentage of assigned packets consumed by self-report, and agreement with packet counts.
OGTT acceptability
Time frame: Baseline and Day 30
Frequency of IV line failure or venous intolerance and intolerance of the OGTT beverage.
CGM acceptability
Time frame: Days 1-30
Completion of 30-day CGM wear, sensor failures, and percentage of possible glucose data points captured.
Diet and activity recall acceptability
Time frame: Baseline and Day 30
Time needed to complete each 24-hour dietary and physical activity recall.
Stool collection acceptability
Time frame: Baseline through Day 30
Percentage of participants who complete both planned stool sample collections.
2 secondary outcomes
Time in range
Time frame: Days 1-30
Glycemic variability
Time frame: Days 1-30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Meng Wang principal investigator
Food is Medicine Institute, Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucralose in people with Prediabetes, run by Tufts University at 1 site in United States.
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 6 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
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?
Recruitment feasibility (time frame: Enrollment period). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.