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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 15 years, 2 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "For over 15 years, the Hamaker Lab at Purdue University has researched the potential of ileal-digesting carbohydrates, such as certain types of starch, in activating L-cells to secrete GLP-1 as a dietary route towards appetite control."
  • "For the current proposal, the investigators hypothesize that a mixture of ileal and colonic gut brain axis (GLP-1)-activating carbohydrates given as a supplement for two months to adolescents with obesity will increase plasma GLP-1 levels, increase satiation, decrease caloric intake, reduce body mass index percentile (BMI%ile), attenuate gut inflammation, and lower liver fat."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how two food carbohydrates affect hunger and feeling full in teens with obesity. Teens mix a special carbohydrate powder with 1 cup of water and drink it twice a day.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Ages 12 to 18 with obesity. The age rule also says “and older,” so ask the study team to confirm the age limit.
  • Have a BMI (a measure of weight compared with height) at or above the 95th percentile for age and sex.
  • Speak English.
  • If taking medicines that affect weight or lower appetite, have been on the same dose for at least 3 months.
  • Can keep taking the same doses of all other medicines during the study.

Who can't join

  • Are pregnant, plan to become pregnant, or are breastfeeding.
  • Have a condition that keeps the body from taking in nutrients well, such as inflammatory bowel disease, celiac disease, or short bowel syndrome.
  • Have had any part of the intestine removed.
  • Have type 1 or type 2 diabetes.
  • Have taken weight-loss medicines or supplements within 30 days before joining.
  • Have another condition that the study doctor thinks could make the study unsafe, affect its results, or prevent you from following study rules.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

IN