Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
150 participants
Apr 5, 2018
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria11
- 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/m\^2 and 40 kg/m\^2
- Consumption of less than or equal to one 12-ounce beverage sweetened with NNS per month or food equivalent
- Healthy with no known active medical condition or illness that requires drug treatment
- Able and willing to consume approximately 4 mg/kg sucralose daily or placebo in form of capsules for
- weeks
- \. Able and willing to avoid eating grapefruit, parsnips, celery, drinking grapefruit juice or sodas containing quinine (e.g. tonic water) during the study
- \. Able and willing to collect stool specimens
- \. Able and willing to consume digoxin and midazolam during study visits
Exclusion Criteria13
- 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.
- Diabetes (fasting blood glucose of 126 mg/dl or higher, or 2-hour blood glucose of 200 or higher on OGTT)
- Taken medications that affect blood sugar in the past 3 months or that include antibiotics
- GI history, at the discretion of the investigators
- Known allergy, sensitivity, or other contraindication to study procedures
- ALT or AST more than 1.5 times the upper limit of normal
- Abnormal thyroid function or abnormal serum electrolytes \& minerals (specifically potassium, calcium, and magnesium)
- Narrow angle glaucoma or untreated open angle glaucoma
- Regular use of alcohol (more than 1 drink per day) or drug use
- History of cardiac abnormalities, especially arrhythmia
- Unable or unwilling to cooperate with study procedures
- 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
- Pregnant, planning to become pregnant or lactating (digoxin and midazolam are Category C and D medications, respectively).
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Interventions
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.
Placebo capsules will be taken orally for 28 days
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03407079