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

Description

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

Healthy VolunteersOverweight
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Healthy VolunteersOverweight

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Healthy Volunteers
Intervention / Treatment

-

Contacts and Locations

Bethesda

National Institutes of Health Clinical Center, Bethesda, Maryland, United States, 20892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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
  • 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).

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

National Institute on Alcohol Abuse and Alcoholism (NIAAA),

Paule V Joseph, C.R.N.P., PRINCIPAL_INVESTIGATOR, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Record Dates

2026-12-31