Glycemic Impact of NNS Via the Gut Microbiome

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tufts University
Study ID
NCT07868432
Status
Enrolling By Invitation

Conditions

  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
35 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sucralose — DIETARY_SUPPLEMENT
    Sucralose (Splenda®): six commercial tabletop packets daily, totaling 72 mg sucralose per day, for 30 days.

Study Details

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.

Key Dates

First listed
Oct 9, 2026
Start date
Oct 31, 2026
Status verified
Oct 2026
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Sucralose Intervention
    Participants will consume six Splenda® packets daily for 30 days.

Primary Outcome Measure

Recruitment feasibility [ Time Frame: Enrollment period ]

Locations (1)

FacilityCityStateZIPSite coordinators
Tufts Medical CenterBostonMassachusetts02111-

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By research site
Tufts Medical Center· Boston, MA

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