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RECRUITING

NCT03407079

PHASE2

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

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2018-04-05

Completion Date

2027-12-26

Last Updated

2026-04-07

Healthy Volunteers

Yes

Conditions

Healthy Volunteers Overweight

Interventions

OTHER

Sucralose

Sucralose is an organochlorine and is approximately 600 times sweeter than sucrose. Participants will receive sucralose (approximately 4mg/kg/day) or placebo by mouth in a capsule for 28 days. This dose corresponds to the amount of sucralose contained in approximately 3 or 4 twelve ounce cans of commercially-available diet soda for a 70 kg adult.

OTHER

Placebo

Placebo capsules will be taken orally for 28 days

* INCLUSION CRITERIA: 1. Age: between 18 and 60 years 2. Female adults who self-identify as Hispanic and/or Black 3. Body weight greater than 50 kg (110 lb) 4. Body mass index between 25 kg/m\^2 and 40 kg/m\^2 5. Consumption of less than or equal to one 12-ounce beverage sweetened with NNS per month or food equivalent 6. Healthy with no known active medical condition or illness that requires drug treatment 7. Able and willing to consume approximately 4 mg/kg sucralose daily or placebo in form of capsules for 4 weeks 8\. Able and willing to avoid eating grapefruit, parsnips, celery, drinking grapefruit juice or sodas containing quinine (e.g. tonic water) during the study 9\. Able and willing to collect stool specimens 10\. Able and willing to consume digoxin and midazolam during study visits EXCLUSION CRITERIA: 1. Current use of prescription or non-prescription medication(s), herbal medications and oral contraceptives are also excluded. Certain exceptions are permitted, including vitamins. Other medications may be permitted at the discretion of the investigators. 2. Diabetes (fasting blood glucose of 126 mg/dl or higher, or 2-hour blood glucose of 200 or higher on OGTT) 3. Taken medications that affect blood sugar in the past 3 months or that include antibiotics 4. GI history, at the discretion of the investigators 5. Known allergy, sensitivity, or other contraindication to study procedures 6. ALT or AST more than 1.5 times the upper limit of normal 7. Abnormal thyroid function or abnormal serum electrolytes \& minerals (specifically potassium, calcium, and magnesium) 8. Narrow angle glaucoma or untreated open angle glaucoma 9. Regular use of alcohol (more than 1 drink per day) or drug use 10. History of cardiac abnormalities, especially arrhythmia 11. Unable or unwilling to cooperate with study procedures 12. Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to provide informed consent, or to comply with study procedures 13. Pregnant, planning to become pregnant or lactating (digoxin and midazolam are Category C and D medications, respectively).

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States