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

Launched by NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA) · Jan 20, 2018

Keywords

ClinConnect Summary

The SweetMeds Study is a clinical trial designed to investigate how the artificial sweetener sucralose affects the way our bodies absorb and process medications. Researchers want to understand if sucralose influences hormone release, gut bacteria, and how fat cells work. This study is open to healthy women aged 18 to 60 who identify as Black or Hispanic, weigh over 110 pounds, and have a body mass index between 25 and 40. Participants should not have any health conditions requiring medication and must limit their intake of artificial sweeteners during the trial.

If you join the study, you will undergo several health checks and provide urine and stool samples over the course of a few weeks. You will also participate in three overnight visits where you will take medication and have blood drawn multiple times. Throughout the study, you will either take sucralose capsules or a placebo (which looks the same but has no active ingredient) for a total of four weeks. You’ll also keep track of what you eat in food diaries. Participants will be contacted by phone after completing the study to check on their well-being. This trial will help researchers learn more about how sucralose might impact health and medication effectiveness.

Gender

FEMALE

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).