The SweetMeds Study: Sucralose and Drug Absorption

This study, called The SweetMeds Study, is looking at how sucralose, a common artificial sweetener, affects how your body absorbs and uses certain medications. Specifically, it will examine its effects on digoxin and midazolam, which are examples of drugs that use specific pathways in the body. Researchers also want to see if sucralose changes hormone levels, gut bacteria, and fat cells. You might be able to join if you are a woman between 18 and 60 years old, identify as Hispanic and/or Black, weigh over 110 pounds, and have a body mass index (BMI) between 25 and 40. The study aims to enroll 150 participants. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants will receive either sucralose or a placebo (an inactive substance). The study plans to enroll 150 participants.
What's involved
You would take sucralose or placebo capsules by mouth for 28 days. You would also answer questions, provide daily urine samples, and one stool sample over 7 days. You must not eat or drink anything with artificial sweeteners throughout the study.
Compensation
Not stated in the trial record.
Follow-up
The primary effects of sucralose on drug processing will be measured at 28 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03407079

Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)

Recruiting
PHASE2Ages 18–60Interventional
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
~150 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:SucralosePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To explore the effects of sucralose (approx 4 mg/kg x 28 days) on pharmacokinetics of digoxin and midazolam, which are representative examples of P-gp and CYP3A dependent medications.
Measured over 28 days
Healthy Volunteers
Overweight

NCT03407079

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Paule V Joseph, C.R.N.P. · PRINCIPAL_INVESTIGATOR · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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  • To explore the effects of sucralose (approx 4 mg/kg x 28 days) on pharmacokinetics of digoxin and midazolam, which are representative examples of P-gp and CYP3A dependent medications.28 days

    To determine the effects of sucralose (4 mg/kg/day) administered to overweight and obese minority women for 28 days on drug metabolism using digoxin and midazolam as probes for P-glycoprotein and CYP3A, respectively.