Actively Recruiting
Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)
Led by National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Updated on 2026-04-29
150
Participants Needed
1
Research Sites
507 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years
- Female adults who self-identify as Hispanic and/or Black
- Body weight greater than 50 kg (110 lb)
- Body mass index between 25 kg/m2 and 40 kg/m2
- Consume less than or equal to one 12-ounce beverage sweetened with non-nutritive sweeteners per month or equivalent in food
- Healthy with no active medical condition requiring drug treatment
- Able and willing to take approximately 4 mg/kg sucralose or placebo capsules daily for 4 weeks
- Able and willing to avoid grapefruit, parsnips, celery, grapefruit juice, and sodas containing quinine during the study
- Able and willing to collect stool samples
- Able and willing to consume digoxin and midazolam during study visits
You will not qualify if you...
- Current use of prescription or non-prescription medications, herbal medications, or oral contraceptives except certain vitamins or as permitted by investigators
- Diabetes with fasting blood glucose 126 mg/dl or higher, or 2-hour glucose 200 mg/dl or higher on oral glucose tolerance test
- Use of medications affecting blood sugar or antibiotics within past 3 months
- Gastrointestinal history as determined by investigators
- Known allergy, sensitivity, or contraindication to study procedures
- Liver enzymes ALT or AST more than 1.5 times upper limit of normal
- Abnormal thyroid function or abnormal serum electrolytes (potassium, calcium, magnesium)
- Narrow-angle glaucoma or untreated open-angle glaucoma
- Regular alcohol use (more than 1 drink per day) or drug use
- History of cardiac abnormalities, especially arrhythmia
- Unable or unwilling to follow study procedures
- Psychiatric or cognitive disorders limiting consent or compliance
- Pregnant, planning pregnancy, or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
P
Paule V Joseph, C.R.N.P.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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