Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Sucralose
- Placebo
Treatment groups
150 Participants
are divided into 2 treatment groupsLocations
1National Institutes of Health Clinical Center20892, BethesdaMaryland, United States
Sponsors and collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Lead sponsor
Source ClinicalTrials.gov