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NCT07823452
Supplementation of Gut-brain Axis (GLP-1)-Activating Carbohydrates for Increasing Satiety in Adolescents With Obesity
Conditions: Obesity & Overweight
Sex: All
Ages: 12 Years – 18 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 62
Sponsor: Indiana University
Location: Riley Hospital for Children at IU Health Indianapolis Indiana
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07823452). StuddyBuddy aggregates publicly available trial information.