Effects of sucralose on how drugs are absorbed and metabolized

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

This study is testing how the artificial sweetener sucralose affects how well medications are absorbed and processed in healthy overweight women.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Female
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT03407079 on ClinicalTrials.gov

What this trial studies

This study investigates how the artificial sweetener sucralose affects the absorption and metabolism of medications in healthy overweight volunteers, particularly focusing on minority women. Participants aged 18-60 will be screened for eligibility and will avoid artificial sweeteners during the study. Over a period of 7 days, they will provide daily urine and stool samples while undergoing assessments of hormone secretion and gut bacteria. The study aims to understand the long-term effects of sucralose on drug metabolism and related health changes.

Who should consider this trial

Good fit: Ideal candidates are healthy women aged 18-60 who self-identify as Hispanic or Black, weigh more than 110 pounds, and have a BMI between 25 and 40.

Not a fit: Patients currently taking prescription medications or with active medical conditions requiring drug treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into how artificial sweeteners like sucralose influence drug effectiveness and safety, particularly for minority populations.

How similar studies have performed: While some studies have explored the effects of artificial sweeteners on metabolism, this specific investigation into sucralose's long-term effects on drug absorption is relatively novel.

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).

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Paule V Joseph, C.R.N.P. — National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Study coordinator: Paule V Joseph, C.R.N.P.

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