Obesity & OverweightPhase 2GUT BOOSTNCT07823452
Supplementation of Gut-brain Axis (GLP-1)-Activating Carbohydrates for Increasing Satiety in Adolescents With Obesity
A Phase 2 study testing gut-brain axis (GLP-1)-activating food carbohydrate in people with Obesity & Overweight, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- gut-brain axis (GLP-1)-activating food carbohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
About this study
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.
Read the detailed description
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.
- Conditions
- Obesity & Overweight
- Being tested
- gut-brain axis (GLP-1)-activating food carbohydrate, starch-based placebo control (commercial maltodextrin)
- Keywords
- adolescents, GLP-1, carbohydrate, weight management
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gut-brain axis (GLP-1)-activating food carbohydrateDrug
Also called 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.
starch-based placebo control (commercial maltodextrin)Other
Also called Placebo starch
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.
| Study group | Role | What they receive |
|---|---|---|
| gut-brain axis (GLP-1)-activating food carbohydrate supplement (raw corn starch + raw potato starch) | Experimental | Intervention with GLP-1-activating carbohydrate Receives: Drug: gut-brain axis (GLP-1)-activating food carbohydrate |
| starch-based fast-digesting placebo control (commercial maltodextrin) | Placebo comparator | Intervention with starch-based placebo Receives: Other: starch-based placebo control (commercial maltodextrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
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.
Measured: 2 months
Changes in caloric intake
Lower caloric intake from the 3-day food log for those consuming the GLP-1-activating carbohydrate
Measured: 2 months
Secondary outcomes (6)
Percent change in BMI and weight
Decrease in body mass index percentile (BMI percentile) and weight
Measured: 2 months
Improvement in fecal calprotectin
Decrease in fecal calprotectin, an indicator of intestinal inflammation, a common condition in obesity
Measured: 2 months
Improvement in serum liver enzymes
Decrease in ALT and AST indicating decreased hepatic steatosis and steatohepatitis
Measured: 2 months
Changes in hepatic steatosis and fibrosis on Fibroscan
Decrease in liver fat (CAP score) and liver stiffness as measured by transient elastography
Measured: 2 months
Percent change in body fat mass
Decrease in total body fat mass as determined by DEXA scan
Measured: 2 months
Changes in gut microbiome composition
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)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Naramore, Indiana University
- Investigators
- Sara K Naramore, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823452
- Sponsor's protocol ID
- 27243
- Acronym
- GUT BOOST
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD information available upon request
Publications
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.
PubMed 37366315Stinson 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.
PubMed 33596309Zhang 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.
PubMed 39116884Wastyk 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.
PubMed 34256014Lomenick 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.
PubMed 19694196Lim 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.
PubMed 34560999Hasek 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.
PubMed 29230947Akhlaghi 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.
PubMed 36193993
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation of Gut-brain Axis (GLP-1)-Activating Carbohydrates for Increasing Satiety in Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT07823452
- Acronym / sponsor ID
- GUT BOOST / 27243
- Conditions
- Obesity & Overweight
- Keywords
- adolescents, GLP-1, carbohydrate, weight management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gut-brain axis (GLP-1)-activating food carbohydrate supplement (raw corn starch + raw potato starch) | Experimental | Drug: gut-brain axis (GLP-1)-activating food carbohydrateIntervention with GLP-1-activating carbohydrate |
| starch-based fast-digesting placebo control (commercial maltodextrin) | Placebo comparator | Other: starch-based placebo control (commercial maltodextrin)Intervention with starch-based placebo |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gut-brain axis (GLP-1)-activating food carbohydrateAlso: GLP-1-activating carbohydrateThe 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. | Drug | gut-brain axis (GLP-1)-activating food carbohydrate supplement (raw corn starch + raw potato starch) |
| starch-based placebo control (commercial maltodextrin)Also: Placebo starchSupplements 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. | Other | starch-based fast-digesting placebo control (commercial maltodextrin) |
Primary outcome
Serum GLP-1 level effect on satiation and caloric intake
Time frame: 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
Time frame: 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
Time frame: 2 months
Lower caloric intake from the 3-day food log for those consuming the GLP-1-activating carbohydrate
6 secondary outcomes
Percent change in BMI and weight
Time frame: 2 months
Improvement in fecal calprotectin
Time frame: 2 months
Improvement in serum liver enzymes
Time frame: 2 months
Changes in hepatic steatosis and fibrosis on Fibroscan
Time frame: 2 months
Percent change in body fat mass
Time frame: 2 months
Changes in gut microbiome composition
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 37366315Jastreboff 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.
- Background: PubMed 33596309Stinson 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.
- Background: PubMed 39116884Zhang 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.
- Background: PubMed 34256014Wastyk 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.
- Background: PubMed 19694196Lomenick 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.
- Background: PubMed 34560999Lim 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.
- Background: PubMed 29230947Hasek 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.
- Background: PubMed 36193993Akhlaghi 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.
- Individual participant dataSharing planned: No. IPD information available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara K Naramore, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gut-brain axis (GLP-1)-activating food carbohydrate in people with Obesity & Overweight, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara K Naramore, MD (317-944-3774, snaramor@iuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum GLP-1 level effect on satiation and caloric intake (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07823452, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.