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Glycemic Impact of NNS Via the Gut Microbiome

Non-Nutritive Sweeteners, Glucose Homeostasis, and the Gut Microbiome in Prediabetes

Sponsor
Tufts University (Academic or other)
Enrolment
10 planned
Conditions
Prediabetes
Interventions
Sucralose
Ages
adults, older adults
Registry
NCT07868432

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Recruitment feasibility
  • Change in OGTT glucose iAUC
  • Retention feasibility
  • Intervention adherence

History

  1. Study completion expected

  2. Primary completion expected

  3. Expected to start

  4. Registered