Tufts University
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: * Assess study feasibility and acceptability, including recruitment, retention, intervention adheren…
Inclusion Criteria: * 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. Exclusion Criteria: * Type 1 diabetes. * Type 2 diabetes. * History of bariatric surgery. * History of organ or tissue transplantation. * Current GLP-1 agonist treatment. * Current metformin treatment. * Current oral steroid medication. * Current immun…
Sucralose (Splenda®): six commercial tabletop packets daily, totaling 72 mg sucralose per day, for 30 days.
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