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NCT03407079 · ClinicalTrials.gov registry record · Phase 2
Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)
A Phase 2 study of Healthy Volunteers and Overweight, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT03407079: Recruiting Phase 2 study of Healthy Volunteers and Overweight, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT03407079 is a Phase 2 study of Healthy Volunteers and Overweight that is actively recruiting participants, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 150 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03407079, a Phase 2 study of Healthy Volunteers and Overweight, is actively recruiting participants, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Placebo
- OTHER Sucralose
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2018-04-05 |
| Est. Completion | 2027-12-26 |
| Phase | Phase 2 |
What NCT03407079 shows while recruiting
NCT03407079 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (69% lower).
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03407079 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03407079 about?
NCT03407079 is a clinical study titled "Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)". 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 metabolize...
What is the current status of trial NCT03407079?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2018-04-05. Estimated completion is 2027-12-26.
What conditions does trial NCT03407079 study?
This clinical trial studies the following conditions: Healthy Volunteers, Overweight.
What interventions are being tested in trial NCT03407079?
The interventions under investigation include: Placebo (OTHER), Sucralose (OTHER).
Who is sponsoring clinical trial NCT03407079?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03407079 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03407079's enrollment target sits among peer trials
150 57th of 283 higher than 225 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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