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.
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
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
Parallel
gut-brain axis (GLP-1)-activating food carbohydrate
DrugThe 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.
starch-based placebo control (commercial maltodextrin)
Other interventionSupplements 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.
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
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.
Changes in caloric intake
Lower caloric intake from the 3-day food log for those consuming the GLP-1-activating carbohydrate
Percent change in BMI and weight
Decrease in body mass index percentile (BMI percentile) and weight
Improvement in fecal calprotectin
Decrease in fecal calprotectin, an indicator of intestinal inflammation, a common condition in obesity
Improvement in serum liver enzymes
Decrease in ALT and AST indicating decreased hepatic steatosis and steatohepatitis
Changes in hepatic steatosis and fibrosis on Fibroscan
Decrease in liver fat (CAP score) and liver stiffness as measured by transient elastography
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