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

NCT07823452 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: GUT BOOST
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity & Overweight

Keywords

adolescents; GLP-1; carbohydrate; weight management

Outcome Measures

Primary Outcomes (3)

• Serum GLP-1 level effect on satiation and caloric intake

  Significant and sustained elevation of postprandial plasma GLP-1 in participants taking the GLP-1-activating carbohydrate compared to the placebo control

  2 months

• Changes in score on the Intuitive Eating Scale for Early Adolescents

  Higher scores on the Intuitive Eating Scale for Early Adolescents in those receiving the GLP-1-activating carbohydrate. This reflects a greater satiation effect and behavior change surrounding satiety.

  2 months

• Changes in caloric intake

  Lower caloric intake from the 3-day food log for those consuming the GLP-1-activating carbohydrate

  2 months

Secondary Outcomes (6)

• Percent change in BMI and weight

  2 months

• Improvement in fecal calprotectin

  2 months

• Improvement in serum liver enzymes

  2 months

• Changes in hepatic steatosis and fibrosis on Fibroscan

  2 months

• Percent change in body fat mass

  2 months

Study Arms (2)

gut-brain axis (GLP-1)-activating food carbohydrate supplement (raw corn starch + raw potato starch)

EXPERIMENTAL

Intervention with GLP-1-activating carbohydrate

Drug: gut-brain axis (GLP-1)-activating food carbohydrate

starch-based fast-digesting placebo control (commercial maltodextrin)

PLACEBO COMPARATOR

Intervention with starch-based placebo

Other: starch-based placebo control (commercial maltodextrin)

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.

Also known as: GLP-1-activating carbohydrate

gut-brain axis (GLP-1)-activating food carbohydrate supplement (raw corn starch + raw potato starch)

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.

Also known as: Placebo starch

starch-based fast-digesting placebo control (commercial maltodextrin)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202, United States

Location

Related Publications (8)

• Jastreboff AM, Kaplan LM, Frias JP, Wu Q, Du Y, Gurbuz S, Coskun T, Haupt A, Milicevic Z, Hartman ML; Retatrutide Phase 2 Obesity Trial Investigators. Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial. N Engl J Med. 2023 Aug 10;389(6):514-526. doi: 10.1056/NEJMoa2301972. Epub 2023 Jun 26.

  PMID: 37366315 BACKGROUND

• Stinson SE, Jonsson AE, Lund MAV, Frithioff-Bojsoe C, Aas Holm L, Pedersen O, Angquist L, Sorensen TIA, Holst JJ, Christiansen M, Holm JC, Hartmann B, Hansen T. Fasting Plasma GLP-1 Is Associated With Overweight/Obesity and Cardiometabolic Risk Factors in Children and Adolescents. J Clin Endocrinol Metab. 2021 May 13;106(6):1718-1727. doi: 10.1210/clinem/dgab098.

  PMID: 33596309 BACKGROUND

• Zhang Y, Higgins CB, Tica S, Adams JA, Sun J, Kelly SC, Zong X, Dietzen DJ, Pietka T, Ballentine SJ, Shriver LP, Patti GJ, Cao Y, DeBosch BJ. Hierarchical tricarboxylic acid cycle regulation by hepatocyte arginase 2 links the urea cycle to oxidative metabolism. Cell Metab. 2024 Sep 3;36(9):2069-2085.e8. doi: 10.1016/j.cmet.2024.07.007. Epub 2024 Aug 7.

  PMID: 39116884 BACKGROUND

• Wastyk HC, Fragiadakis GK, Perelman D, Dahan D, Merrill BD, Yu FB, Topf M, Gonzalez CG, Van Treuren W, Han S, Robinson JL, Elias JE, Sonnenburg ED, Gardner CD, Sonnenburg JL. Gut-microbiota-targeted diets modulate human immune status. Cell. 2021 Aug 5;184(16):4137-4153.e14. doi: 10.1016/j.cell.2021.06.019. Epub 2021 Jul 12.

  PMID: 34256014 BACKGROUND

• Lomenick JP, White JR, Smart EJ, Clasey JL, Anderson JW. Glucagon-like peptide 1 and pancreatic polypeptide responses to feeding in normal weight and overweight children. J Pediatr Endocrinol Metab. 2009 Jun;22(6):493-500. doi: 10.1515/jpem.2009.22.6.493.

  PMID: 19694196 BACKGROUND

• Lim J, Ferruzzi MG, Hamaker BR. Dietary starch is weight reducing when distally digested in the small intestine. Carbohydr Polym. 2021 Dec 1;273:118599. doi: 10.1016/j.carbpol.2021.118599. Epub 2021 Aug 24.

  PMID: 34560999 BACKGROUND

• Hasek LY, Phillips RJ, Zhang G, Kinzig KP, Kim CY, Powley TL, Hamaker BR. Dietary Slowly Digestible Starch Triggers the Gut-Brain Axis in Obese Rats with Accompanied Reduced Food Intake. Mol Nutr Food Res. 2018 Mar;62(5):10.1002/mnfr.201700117. doi: 10.1002/mnfr.201700117. Epub 2018 Feb 22.

  PMID: 29230947 BACKGROUND

• Akhlaghi M. The role of dietary fibers in regulating appetite, an overview of mechanisms and weight consequences. Crit Rev Food Sci Nutr. 2024;64(10):3139-3150. doi: 10.1080/10408398.2022.2130160. Epub 2022 Oct 4.

  PMID: 36193993 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Brain-Gut Axis

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sara K Naramore, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara K Naramore, MD

CONTACT

317-944-3774; snaramor@iuhealth.org

Brian DeBosch, MD, PhD

CONTACT

317-944-3774; bdebosch@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 16, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)