RECRUITING

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

Conditions

Healthy Volunteers Overweight Drug Metabolism Artificial Sweetener P-Glycoprotein Cytochrome P450 Microbiome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2018-04-05

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03407079

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.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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).

Inclusion Criteria

Exclusion 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).

Contacts and Locations

Study Contact

Paule V Joseph, C.R.N.P.

CONTACT

(301) 827-5234

paule.joseph@nih.gov

Principal Investigator

Paule V Joseph, C.R.N.P.

PRINCIPAL_INVESTIGATOR

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-04-05

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2018-04-05

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Drug Metabolism
Artificial Sweetener
P-Glycoprotein
Cytochrome P450
Microbiome

Additional Relevant MeSH Terms

Healthy Volunteers
Overweight