Supplementation of Gut-brain Axis (GLP-1)-Activating Carbohydrates for Increasing Satiety in Adolescents With Obesity

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07823452
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • gut-brain axis (GLP-1)-activating food carbohydrate — DRUG
    The primary study intervention will be providing 2-months of supplementation of either a gut-brain axis (GLP-1)-activating food carbohydrate supplement (raw corn starch + raw potato starch). Supplements will be provided as 10 gram (2 tsp) sachets containing the test or control food carbohydrates, a viscous agent (guar gum), and a fruit flavoring to be mixed with 200 ml (6.6 oz) water and consumed at breakfast and 2 hours (+/- 60 minutes) prior to dinner daily.
  • starch-based placebo control (commercial maltodextrin) — OTHER
    Supplements will be provided as 10 gram (2 tsp) sachets containing the placebo control food carbohydrates, a viscous agent (guar gum), and a fruit flavoring to be mixed with 200 ml (6.6 oz) water and consumed at breakfast and 2 hours (+/- 60 minutes) prior to dinner daily.

Study Details

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.

Key Dates

First listed
Sep 16, 2026
Start date
Oct 1, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: gut-brain axis (GLP-1)-activating food carbohydrate supplement (raw corn starch + raw potato starch)
    Intervention with GLP-1-activating carbohydrate
  • Placebo Comparator: starch-based fast-digesting placebo control (commercial maltodextrin)
    Intervention with starch-based placebo

Primary Outcome Measure

Serum GLP-1 level effect on satiation and caloric intake [ Time Frame: 2 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Riley Hospital for Children at IU HealthIndianapolisIndiana46202-

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By research site
Riley Hospital for Children at IU Health· Indianapolis, IN

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