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临床试验/NCT07823452
NCT07823452尚未招募2 期

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

Indiana University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2026年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
入组人数
62
试验地点
1
主要终点
Serum GLP-1 level effect on satiation and caloric intake

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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

Experimental

Intervention with GLP-1-activating carbohydrate

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

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

Placebo Comparator

Intervention with starch-based placebo

干预措施: starch-based placebo control (commercial maltodextrin) (Other)

结局指标

主要结局

Serum GLP-1 level effect on satiation and caloric intake

时间窗: 2 months

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

Changes in score on the Intuitive Eating Scale for Early Adolescents

时间窗: 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.

Changes in caloric intake

时间窗: 2 months

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

次要结局

  • 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)
  • Changes in gut microbiome composition(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Naramore

Associate Professor of Clinical Pediatrics

Indiana University

研究点 (1)

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