Gut-brain Axis Activating Carbohydrates for Obesity

(GUT BOOST Trial)

BD
SK
Overseen BySara K Naramore, MD
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how special carbohydrates might help control appetite by affecting the brain's hunger signals in children with obesity. Researchers aim to determine if a specific carbohydrate powder, mixed with water and taken twice daily, can increase feelings of fullness. This carbohydrate targets the gut-brain axis, specifically activating GLP-1, a hormone involved in hunger regulation. The trial compares this with a placebo, a harmless substance resembling the treatment. Children aged 12 to 18 with obesity, who are on stable medication doses, may qualify for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the carbohydrates used in this trial, which activate the gut-brain connection, are generally safe. These carbohydrates come from a mix of raw corn starch and raw potato starch. Past studies have tested this combination for its ability to increase GLP-1, a hormone that helps control appetite. The results showed that this mix is well-tolerated by the body, with no serious side effects reported.

Another study found that these starches effectively improved communication between the gut and brain, reducing daily food intake without causing harm. These findings suggest that this approach is safe for those considering joining a clinical trial.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about these treatments for obesity because they target the gut-brain axis, specifically activating GLP-1, a hormone that plays a crucial role in regulating appetite and metabolism. Unlike current options like medications that suppress appetite or block fat absorption, this treatment uses natural food carbohydrates, like raw corn starch and raw potato starch, to stimulate the body's own pathways for weight regulation. This approach could offer a more natural and potentially safer alternative to traditional pharmacological interventions.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will compare the effects of a gut-brain axis (GLP-1)-activating food carbohydrate supplement, made of raw corn starch and raw potato starch, with a starch-based fast-digesting placebo control using commercial maltodextrin. Research has shown that resistant starches, like those in raw corn and potato starch, can aid weight loss and improve insulin use in the body. One study found that participants who consumed resistant starches lost an average of 2.8 kilograms over eight weeks. These starches increase a hormone called GLP-1, which controls appetite and enhances feelings of fullness. GLP-1 also improves insulin management, benefiting weight and blood sugar control. Additionally, resistant starches have been linked to reduced belly fat and better gut health. Overall, these carbohydrates appear promising for aiding weight loss and enhancing metabolism.12567

Who Is on the Research Team?

SK

Sara K Naramore, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for adolescents who have obesity. Participants should be generally healthy aside from their weight and able to drink a carbohydrate powder mixed with water twice daily.

Inclusion Criteria

English-speaking subjects
My child has been on the same dose of medication for 3 months that affects weight or appetite.
I can keep my current medication doses the same during the study.
See 1 more

Exclusion Criteria

Any condition that would compromise the well-being of the subject, the study, or prevent meeting study requirements as judged by the investigator
I have a condition that makes it hard for my body to absorb nutrients.
I am a child diagnosed with Type 1 or Type 2 diabetes.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a mixture of ileal and colonic gut-brain axis (GLP-1)-activating carbohydrates as a supplement for two months

8 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • gut-brain axis (GLP-1)-activating food carbohydrate

Trial Overview

The study compares a special carbohydrate that activates the gut-brain axis (GLP-1) with a placebo starch powder, both taken in water twice daily, to see which helps teens feel fuller.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: gut-brain axis (GLP-1)-activating food carbohydrate supplement (raw corn starch + raw potato starch)Experimental Treatment1 Intervention
Group II: starch-based fast-digesting placebo control (commercial maltodextrin)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

Citations

Supplementation of Gut-brain Axis (GLP-1)-Activating ...

This study is being conducted to better understand how two food carbohydrates affect the appetite control center of the brain. The investigators ...

Activating GLP-1 Through Natural, Food-Based Supplements

GLP-1 prescription medications are highly effective in promoting weight loss and treating Type 2 diabetes. In the first clinical study of a carbohydrate ...

Role of Resistant Starch in Improving Gut Health, Adiposity ...

Additionally, consumption of resistant starch was associated with reduced abdominal fat and improved insulin sensitivity. Increased serum glucagon-like peptide ...

Resistant starch intake facilitates weight loss in humans by ...

Here, we show that RS supplementation for 8 weeks can help to achieve weight loss (mean −2.8 kg) and improve insulin resistance in individuals ...

Resistant starch and the gut microbiome - PMC - NIH

The enhancement in GLP-1, specifically, improves insulin sensitivity, representing a potential therapeutic avenue for managing dietary antigens ...

Decoding The Gut-Brain-Microbiome Axis In GLP-1 Signaling

GLP-1RAs may improve gut health by influencing gut motility, altering luminal pH, and changing bile acid metabolism, thereby encouraging the growth of ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29230947/

Dietary Slowly Digestible Starch Triggers the Gut-Brain Axis in ...

Conclusion: SDS with digestion into the ileum reduced daily food intake and paralleled suppressed expression of appetite-stimulating neuropeptide genes ...