Supplementation of Gut-Brain Axis (Glp-1)-Activating Carbohydrates for Increasing Satiety in Adolescents with Obesity

Investigating the Effects of Carbohydrates on Appetite in Adolescents with Excess Body Fat

S
Sara Naramore

Primary Investigator

Enrolling By Invitation
12 years - 18 years
All
Phase N/A
50 participants needed
1 Location

Brief description of study

Glucagon-like peptide-1 (GLP-1) drugs have quickly become a standard treatment for adults with obesity. These drugs target the appetite control center of the brain, which slows 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. We want to see if a special carbohydrate powder that is mixed with 1 cup of water twice a day will affect appetite.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Study participants will be identified through the IU Pediatric Obesity clinical registry (#1810758741) and will be enrolled from the Pediatric Weight Management Program at Riley Hospital for Children. Additional clinic locations for enrollment include IU North Hospital and Methodist Medical Plaza South.  Potential participants will be screened for inclusion and exclusion criteria by study staff. Potential participants and families will be contacted by phone or in-person in a private clinic room with additional study information. All study visits will be done at the Children's Clinical Research Center.

Detailed description of study

The research is designed to study the relationship between the dietary supplement’s effect on normal structure or function in humans or characterize the mechanism by which a dietary supplement acts to maintain such structure or function. The overall objective is to test a combination of two food carbohydrates designed to activate the BLP-1 release for physiologic appetite suppression.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Obesity, Overweight, Riley
  • Age: 12 years - 18 years
  • Gender: All

Inclusion Criteria

  • Children ages 12 to ≤18 years and older with obesity, a BMI ≥95% for age and sex
  • English-speaking subjects
  • Children who have been on stable dosing of medications for 3 months which secondarily lead to weight gain, weight loss, or appetite suppression
  • Children able to stay on a stable dose of all concomitant medications throughout the study treatment period

Exclusion Criteria

  • Females who are or planning to become pregnant or are breastfeeding
  • Children with malabsorptive disorders including inflammatory bowel disease,  Celiac disease, and short bowel syndrome
  • Children with any intestinal resection
  • Children with Type 1 or Type 2 Diabetes Mellitus
  • Children taking any medications or supplements for weight loss within 30 days prior to enrollment in the study
  • Subject has any condition that, in the opinion of the investigator, would compromise the well-being of the subject or would compromise the study or prevent the subject from meeting or performing study requirements. 

This study investigates how certain carbohydrates affect the appetite control center in the brain of adolescents with obesity. The purpose is to understand if a special carbohydrate powder, when mixed with water and consumed twice daily, can influence feelings of fullness. Researchers are focusing on adolescents because similar treatments are already used in adults with obesity.

Participants will consume a carbohydrate powder mixed with water twice a day. The study will observe how this affects their appetite. The research is conducted at the Children's Clinical Research Center, where participants will be monitored for any changes in their appetite control, without altering their existing medications.

  • Who can participate: Children aged 12 to 18 years with excess body fat, having a BMI at or above the 95th percentile, can participate. They must speak English and maintain stable medication doses that affect weight or appetite.
  • Study details: Participants will consume a carbohydrate powder mixed with water twice daily. The study will observe effects on their appetite control mechanisms.
Updated on 07 Jul 2026. Study ID: PGI-IIR-GUT-BOOST, 27243
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only