An interventional study of Sucralose in Prediabetes, sponsored by Tufts University. Enrolling by invitation at 1 site in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Tufts University · Not applicable, Interventional, and Other
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.
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:
1,021 studies on the registry are indexed under Prediabetic State; 242 are open to participants now.
This study's planned enrollment of 10 is below the median of 66 across 861 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Tufts University is the lead sponsor of 228 studies on the registry; 25 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will consume six Splenda® packets daily for 30 days.
Dietary Supplement: Sucralose
Sucralose (Splenda®): six commercial tabletop packets daily, totaling 72 mg sucralose per day, for 30 days.
Recruitment feasibility
Number and proportions of participants reached, eligible, agreeing to participate, and enrolled, plus time required to enroll 10 participants.
Time frame: 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.
Time frame: Baseline and Day 30
Retention feasibility
Percentage of enrolled participants who attend the post-intervention visit.
Time frame: Day 30
Intervention adherence
Percentage of daily consumption surveys completed, percentage of assigned packets consumed by self-report, and agreement with packet counts.
Time frame: Days 1-30
OGTT acceptability
Frequency of IV line failure or venous intolerance and intolerance of the OGTT beverage.
Time frame: Baseline and Day 30
CGM acceptability
Completion of 30-day CGM wear, sensor failures, and percentage of possible glucose data points captured.
Time frame: Days 1-30
Diet and activity recall acceptability
Time needed to complete each 24-hour dietary and physical activity recall.
Time frame: Baseline and Day 30
Stool collection acceptability
Percentage of participants who complete both planned stool sample collections.
Time frame: Baseline through Day 30
Time in range
Percentage of CGM readings with glucose below 140 mg/dL.
Time frame: Days 1-30
Glycemic variability
Coefficient of variation calculated from CGM data.
Time frame: Days 1-30
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.
Of 415 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 2 months is below that.
Counting every sponsor, half of 466 studies reached it within 24 months; a quarter within 11 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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