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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 311 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Re-verified, no change to tracked fields
  3. Re-verified, no change to tracked fields
  4. Secondary endpoints: details revised at 1 of 1 entry
  5. 17 versions Re-verified since Feb 27, 2026, no change to tracked fieldsv291-v307
Show 29 earlier versionsHide 29 earlier versions
  1. Primary and study completion dates: Dec 31, 2026 to Dec 26, 2027v290
  2. 3 versions Re-verified since Nov 25, 2025, no change to tracked fieldsv287-v289
  3. Study Status, Outcome Measuresv286
  4. 24 versions Re-verified since Dec 20, 2024, no change to tracked fieldsv262-v285
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Artificial sweeteners like sucralose are found in many foods and drinks. Sucralose might affect hormones and cause health changes. Objective: To see if sucralose changes how medicines are absorbed and processed, how hormones are secreted, gut bacteria, and how fat cells are metabolized. Eligibility: People ages 18-60 who: * Are black or Hispanic * Weigh more than 110 pounds * Have a body mass index of 25-40 * Do not have a condition that requires drug treatment Design: Participants will be screened with: * Medical history * Physical exam * Blood, heart, and urine tests Participants must not eat or drink anything with artificial sweeteners throughout the study. Over 7 days, Participants will answer questions, and give daily urine samples and 1 stool sample. Participants will repeat these throughout the study. Overnight Visit 1: participants will fast starting the night before. They will get breakfast at the visit. The visit includes: * An IV will be placed in the arm. Participants will get 2 tablets of medicines. Blood will be drawn several times over 24 hours. * A piece of fat tissue may be taken from the abdomen (biopsy). * Participants will have a sweet drink. Blood samples will be taken over 2 hours. Then participants will be randomly assigned to take either a sucralose capsule or placebo. They will take it twice a day for 2 weeks. They will complete two 24-hour food diaries. Overnight Visit 2 repeats Visit 1 except the biopsy. Then participants will take the capsules for another 2 weeks. Overnight Visit 3 repeats Visit 1. Participants may be contacted by phone within 4 weeks after they finish.
Trial Details
NCT Number NCT03407079
Lead Sponsor National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
(from sponsor)		 Healthy Volunteers, Overweight
Related terms Overweight
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov