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

15. september 2026 opdateret af: Sara Naramore, Indiana University
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.

Studieoversigt

Detaljeret beskrivelse

Glucagon-like peptide-1 (GLP-1) receptor agonist drugs, such as semaglutide and tirzepatide, have quickly become a standard treatment for adults with obesity. Adolescents, on the other hand, have limited access to FDA-approved medications for obesity, even though semaglutide has been shown to lead to significant improvements in body mass index and co-morbidities of obesity for youth over age 12. Obesity is defined as a body mass index greater than the 95th percentile for age and sex. Moreover, GLP-1 agonists are effective in reducing appetite and food intake and result in notable weight reduction. These drugs trigger an innate physiological system of the body that, among other targets, signals the appetite control center of the brain, the hypothalamus, to convey a feeling of fullness, as well as to slow the rate of stomach emptying. This "gut-brain axis" communication system is naturally activated by digested macronutrients through their interaction with the enteroendocrine cells, particularly the L-cells which are found in greater abundance in the distal small intestine (ileum) and proximal colon. 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. In long-term feeding rat and mouse trials, the investigators have shown ileal activation of the gut-brain axis and sustained increase in plasma GLP-1 that coincided with reduction in food intake and weight management using developed methods to target starch digestion to the ileum (a starch-based fabricated microsphere and precise a-amylase inhibition to slow starch digestion. Additionally, short-chain fatty acids (SCFAs) produced by dietary fiber fermentation by gut microbes trigger secretion of GLP-1 for satiation. SCFAs also reduce gut inflammation that is linked to obesity. Of note, there are other gut hormones secreted by L-cells (e.g., Gastric Inhibitory Polypeptide (GIP), Peptide YY (PYY), oxyntomodulin) that influence the gut-brain axis for appetite modulation.

Interestingly, in mouse trials with fabricated ileal-digesting carbohydrates for gut-brain axis activation, the investigators also found reduction in fatty livers of obese mice.

Even though GLP-1 agonist drugs are highly effective in reducing weight in individuals with obesity and lowering indices of associated health conditions (e.g., Hemoglobin A1c for prediabetes/diabetes), most individuals cannot remain on the medication indefinitely due to expense and side effects, and some simply prefer not to take the weight-reducing drugs, especially at a younger age. It is, therefore, timely to test a dietary approach to activate the innate GLP-1-secreting cells in the gastrointestinal tract, through a safe and inexpensive science-based carbohydrate supplement the investigators have tested and partly optimized.

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.

Our overall objective is to test a combination of two food carbohydrates designed to activate the gut-brain axis through GLP-1 release for physiologic appetite suppression. The investigators will examine the central hypothesis that carbohydrates that modulate the gut-brain axis represent an efficacious strategy by which to reduce appetite and body weight in adolescents with obesity.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

62

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Brian DeBosch, MD, PhD
  • Telefonnummer: 317-944-3774
  • E-mail: bdebosch@iu.edu

Studiesteder

    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Riley Hospital for Children at IU Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: gut-brain axis (GLP-1)-activating food carbohydrate supplement (raw corn starch + raw potato starch)
Intervention with GLP-1-activating carbohydrate
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.
Andre navne:
  • GLP-1-activating carbohydrate
Placebo komparator: starch-based fast-digesting placebo control (commercial maltodextrin)
Intervention with starch-based placebo
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.
Andre navne:
  • Placebo starch

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum GLP-1 level effect on satiation and caloric intake
Tidsramme: 2 months
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
Tidsramme: 2 months
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
Tidsramme: 2 months
Lower caloric intake from the 3-day food log for those consuming the GLP-1-activating carbohydrate
2 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent change in BMI and weight
Tidsramme: 2 months
Decrease in body mass index percentile (BMI percentile) and weight
2 months
Improvement in fecal calprotectin
Tidsramme: 2 months
Decrease in fecal calprotectin, an indicator of intestinal inflammation, a common condition in obesity
2 months
Improvement in serum liver enzymes
Tidsramme: 2 months
Decrease in ALT and AST indicating decreased hepatic steatosis and steatohepatitis
2 months
Changes in hepatic steatosis and fibrosis on Fibroscan
Tidsramme: 2 months
Decrease in liver fat (CAP score) and liver stiffness as measured by transient elastography
2 months
Percent change in body fat mass
Tidsramme: 2 months
Decrease in total body fat mass as determined by DEXA scan
2 months
Changes in gut microbiome composition
Tidsramme: 2 months
For the gut microbiome, the investigators expect to see greater short-chain fatty acids (SCFAs), including butyrate, that is related to lower inflammation and an increase in certain beneficial SCFA-producing bacteria (e.g., families Ruminococcaceae, Lachnospiraceae, Bacteroidaceae)
2 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Sara K Naramore, MD, Indiana University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

3. september 2026

Først indsendt, der opfyldte QC-kriterier

15. september 2026

Først opslået (Faktiske)

16. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

IPD information available upon request

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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