Could your diet soda change how your medicine works?
NCT ID NCT03407079
First seen Jun 26, 2026 · Last updated Sep 02, 2026 · Updated 8 times
Summary
This study looks at whether the artificial sweetener sucralose (found in many diet drinks and foods) changes how the body absorbs and processes certain medications. Researchers will give 150 healthy, overweight Black and Hispanic women either sucralose or a placebo capsule for 28 days. They will measure drug levels, hormone changes, gut bacteria, and fat cell activity to see if sucralose has any effect.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sucralose
- What this could lead to
- If it works, this could help doctors understand whether artificial sweeteners like sucralose change how medications work in the body.
- What could go wrong
- This is a small, early-phase study in healthy volunteers, so results may not apply to people with medical conditions or those taking long-term medications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2018
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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