Sucralose for Prediabetes

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Tufts University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

MW

Meng Wang

Principal Investigator

Food is Medicine Institute, Tufts University

Are You a Good Fit for This Trial?

This trial is for adults with prediabetes. People who do not have prediabetes or have other health conditions that could interfere with the study may not be eligible.

Inclusion Criteria

Low non-nutritive sweetener use, defined as less than once per week
I have been diagnosed with prediabetes.
HbA1c measured within the past 6 months between 5.7% and 6.4%
See 3 more

Exclusion Criteria

I have type 1 diabetes.
I have type 2 diabetes.
I do not have severe digestive system disease.
See 11 more

What Are the Treatments Tested in This Trial?

Interventions

  • Sucralose

Trial Overview

The study tests if daily use of sucralose (Splenda) for 30 days affects blood sugar and gut bacteria in people with prediabetes. Participants will wear a glucose monitor, take glucose tolerance tests, and provide stool samples.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Sucralose InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials
271
Recruited
595,000+

Tufts Medical Center

Collaborator

Trials
264
Recruited
264,000+