Status:
RECRUITING
Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Healthy Volunteers
Overweight
Eligibility:
FEMALE
18-60 years
Phase:
PHASE2
Brief 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 a...
Detailed Description
Background: Consumption of non-nutritive sweeteners (NNS) has dramatically increased worldwide and is more prevalent in women than men. Similarly, obesity rates have continued to rise, most notably i...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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
- 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:
- 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).
Exclusion
Key Trial Info
Start Date :
April 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03407079
Start Date
April 5 2018
End Date
December 31 2026
Last Update
January 8 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892