- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07823452
Supplementation of Gut-brain Axis (GLP-1)-Activating Carbohydrates for Increasing Satiety in Adolescents With Obesity (GUT BOOST)
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní kontakt
- Jméno: Sara K Naramore, MD
- Telefonní číslo: 317-944-3774
- E-mail: snaramor@iuhealth.org
Studijní záloha kontaktů
- Jméno: Brian DeBosch, MD, PhD
- Telefonní číslo: 317-944-3774
- E-mail: bdebosch@iu.edu
Studijní místa
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Indiana
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Indianapolis, Indiana, Spojené státy, 46202
- Riley Hospital for Children at IU Health
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: gut-brain axis (GLP-1)-activating food carbohydrate supplement (raw corn starch + raw potato starch)
Intervention with GLP-1-activating carbohydrate
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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.
Ostatní jména:
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Komparátor placeba: starch-based fast-digesting placebo control (commercial maltodextrin)
Intervention with starch-based placebo
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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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Serum GLP-1 level effect on satiation and caloric intake
Časové okno: 2 months
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Significant and sustained elevation of postprandial plasma GLP-1 in participants taking the GLP-1-activating carbohydrate compared to the placebo control
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2 months
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Changes in score on the Intuitive Eating Scale for Early Adolescents
Časové okno: 2 months
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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.
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2 months
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Changes in caloric intake
Časové okno: 2 months
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Lower caloric intake from the 3-day food log for those consuming the GLP-1-activating carbohydrate
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2 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percent change in BMI and weight
Časové okno: 2 months
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Decrease in body mass index percentile (BMI percentile) and weight
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2 months
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Improvement in fecal calprotectin
Časové okno: 2 months
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Decrease in fecal calprotectin, an indicator of intestinal inflammation, a common condition in obesity
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2 months
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Improvement in serum liver enzymes
Časové okno: 2 months
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Decrease in ALT and AST indicating decreased hepatic steatosis and steatohepatitis
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2 months
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Changes in hepatic steatosis and fibrosis on Fibroscan
Časové okno: 2 months
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Decrease in liver fat (CAP score) and liver stiffness as measured by transient elastography
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2 months
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Percent change in body fat mass
Časové okno: 2 months
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Decrease in total body fat mass as determined by DEXA scan
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2 months
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Changes in gut microbiome composition
Časové okno: 2 months
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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)
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2 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Sara K Naramore, MD, Indiana University
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- GUT BOOST
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Studuje lékový produkt regulovaný americkým FDA
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