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Gut-brain Axis Activating Carbohydrates for Obesity

(GUT BOOST Trial)

BD
SK
Overseen BySara K Naramore, MD
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Indiana University
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Glucagon-like peptide (GLP1) drugs have quickly become a standard treatment for the adults with obesity. These drugs target the appetite control center of the brain, which clows the rate of stomach emptying, and makes a person feel full. The researchers are exploring this response in children. This study is being conducted to better understand how two food carbohydrates affect the appetite control center of the brain. The investigators want to see if a special carbohydrate powder that is mixed with 1 cup of water twice a day will appetite.

Who Is on the Research Team?

SK

Sara K Naramore, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for adolescents who have obesity. Participants should be generally healthy aside from their weight and able to drink a carbohydrate powder mixed with water twice daily.

Inclusion Criteria

English-speaking subjects
My child has been on the same dose of medication for 3 months that affects weight or appetite.
I can keep my current medication doses the same during the study.
See 1 more

Exclusion Criteria

Any condition that would compromise the well-being of the subject, the study, or prevent meeting study requirements as judged by the investigator
I have a condition that makes it hard for my body to absorb nutrients.
I am a child diagnosed with Type 1 or Type 2 diabetes.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • gut-brain axis (GLP-1)-activating food carbohydrate

Trial Overview

The study compares a special carbohydrate that activates the gut-brain axis (GLP-1) with a placebo starch powder, both taken in water twice daily, to see which helps teens feel fuller.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: gut-brain axis (GLP-1)-activating food carbohydrate supplement (raw corn starch + raw potato starch)Experimental Treatment1 Intervention
Group II: starch-based fast-digesting placebo control (commercial maltodextrin)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

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