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

NCT03407079 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-29

No results posted yet for this study

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 are absorbed and processed, how hormones are secreted, gut bacteria, and how fat cells are metabolized.

Eligibility:

People ages 18-60 who:

* Are black or Hispanic
* Weigh more than 110 pounds
* Have a body mass index of 25-40
* Do not have a condition that requires drug treatment

Design:

Participants will be screened with:

* Medical history
* Physical exam
* Blood, heart, and urine tests

Participants must not eat or drink anything with artificial sweeteners throughout the study.

Over 7 days, Participants will answer questions, and give daily urine samples and 1 stool sample. Participants will repeat these throughout the study.

Overnight Visit 1: participants will fast starting the night before. They will get breakfast at the visit. The visit includes:

* An IV will be placed in the arm. Participants will get 2 tablets of medicines. Blood will be drawn several times over 24 hours.
* A piece of fat tissue may be taken from the abdomen (biopsy).
* Participants will have a sweet drink. Blood samples will be taken over 2 hours.

Then participants will be randomly assigned to take either a sucralose capsule or placebo. They will take it twice a day for 2 weeks. They will complete two 24-hour food diaries.

Overnight Visit 2 repeats Visit 1 except the biopsy.

Then participants will take the capsules for another 2 weeks.

Overnight Visit 3 repeats Visit 1.

Participants may be contacted by phone within 4 weeks after they finish.

Conditions

Interventions

OTHER

Sucralose

Sucralose is an organochlorine and is approximately 600 times sweeter than sucrose. Participants will receive sucralose (approximately 4mg/kg/day) or placebo by mouth in a capsule for 28 days. This dose corresponds to the amount of sucralose contained in approximately 3 or 4 twelve ounce cans of commercially-available diet soda for a 70 kg adult.

OTHER

Placebo

Placebo capsules will be taken orally for 28 days

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    lead NIH

Principal Investigators

  • Paule V Joseph, C.R.N.P. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2027-12-26
Completion
2027-12-26

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03407079 on ClinicalTrials.gov