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Sucralose for Healthy Subjects

Phase 2
Recruiting
Led By Kristina I Rother, M.D.
Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight greater than 50 kg (110 lb)
Healthy with no known active medical condition or illness that requires drug treatment
Must not have
Diabetes (fasting blood glucose of 126 mg/dl or higher, or 2-hour blood glucose of 200 or higher on OGTT)
Narrow angle glaucoma or untreated open angle glaucoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Summary

This trial looks at the effects of the artificial sweetener sucralose on the body.

Who is the study for?
This study is for Black or Hispanic adults aged 18-60, with a BMI of 25-40 and weighing over 110 pounds. They must be healthy without any conditions needing medication, not consume much artificial sweetener, and agree to avoid certain foods during the trial.
What is being tested?
The SweetMeds Study is testing if sucralose affects how the body absorbs and processes medicines. Participants will take either sucralose capsules or a placebo twice daily for four weeks while their hormone levels, gut bacteria, fat metabolism, and drug absorption are monitored.
What are the potential side effects?
Potential side effects aren't specified but may include discomfort from blood draws or biopsies, reactions to the study drugs (digoxin and midazolam), changes in gut bacteria balance or hormone levels due to sucralose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh more than 110 pounds.
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I am healthy and not on medication for any active illness.
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I am willing and able to provide stool samples.
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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes based on my blood sugar levels.
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I have narrow angle glaucoma or untreated open angle glaucoma.
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I have a history of heart problems, especially irregular heartbeats.
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I am not pregnant, planning to become pregnant, or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To explore the effects of sucralose (approx 4 mg/kg x 28 days) on pharmacokinetics of digoxin and midazolam, which are representative examples of P-gp and CYP3A dependent medications.
Secondary study objectives
To investigate the effects of sucralose on glucose metabolism and incretin secretion, lipid metabolism, and intestinal microbiome

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Study Arm 1Experimental Treatment1 Intervention
Participants will receive sucralose capsules (approximately 4mg/kg/day) by mouth for 28 days.
Group II: Study Arm 2Placebo Group1 Intervention
Participants will receive placebo capsules by mouth for 28 days.

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Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
2,014 Previous Clinical Trials
2,696,684 Total Patients Enrolled
106 Trials studying Obesity
102,722 Patients Enrolled for Obesity
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Lead Sponsor
823 Previous Clinical Trials
1,161,156 Total Patients Enrolled
3 Trials studying Obesity
333 Patients Enrolled for Obesity
Kristina I Rother, M.D.Principal InvestigatorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
5 Previous Clinical Trials
15,148 Total Patients Enrolled
2 Trials studying Obesity
15 Patients Enrolled for Obesity
~39 spots leftby Dec 2026
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