Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)
- Healthy Volunteers
- Overweight
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Enrolment target
- 150
- Started
- 5 April 2018
- Main results due
- 26 December 2027
- Study sites
- 1
- Registry updated
- 28 September 2026
Can you take part?
- Ages 18 years to 60 years.
- Women only.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
* 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).
What this study is about
In the sponsor’s own words, from the registry.
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....
Study sites(1)
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT03407079. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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