- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07572513
Slowly Digestible Carbohydrates for GLP-1 Secretion
The goal of this clinical trail is to learn if the hormone, glucagon-like peptide-1 (GLP-1), is stimulated by slowly digestible carbohydrates (SDCs) in healthy adults. In the current study, researchers will observe the amount of SDC that results in clinically meaningful levels of GLP-1, shown by an increase in feelings of fullness and a decrease in hunger, and how long an elevated level of GLP-1 lasts after starch consumption. Researchers aim to address two questions: What amount of SDC maximizes GLP-1-mediated satiety, and does the impact to satiety continue in a second meal? The overall goal is to maximize ileal-digesting SDC's potential use as a food-based agent for weight loss.
Researchers will compare 20, 40, and 60 g of raw corn starch compared to a maltodextrin control on total plasma GLP-1 concentrations, insulin, and blood glucose at baseline and 15, 30, 60, 90, 120, and 180 minutes post-consumption of SDC. Researchers will also measure satiety at baseline, 60, 120, 180 minutes and after a second meal.
There will be a total of 4 study visits with a least a 7-day break between visits. At each study visit, participants will:
- Consume a randomized test beverage (SDC or maltodextrin)
- Receive a blood draw at 7 timepoints over 3 hrs
- Take a satiety questionnaire 5 times over 3 hrs
- Consume a standardized lunch 3 hrs after the test beverage consumption
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bruce R Hamaker, Ph.D.
- Phone Number: 765-494-5668
- Email: hamakerb@purdue.edu
Study Contact Backup
- Name: Erica de Jong, B.s.
- Phone Number: 7654963802
- Email: dejonge@purdue.edu
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47907
- Recruiting
- Clinical Research Center at Purdue University
-
Contact:
- Cheryl Armstrong, Ph.D.
- Phone Number: 765-496-6275
- Email: armstroc@purdue.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy population
- BMI between 18.5 and 24.9 kg/m2
- Adults 18 - 45 years old
- Men or women
- Able to read/speak English
- Fasting blood glucose levels ≤100 mg/dL
- HbA1c ≤ 5.7%
Exclusion Criteria:
- Participants with 18 > Years of Age > 45 will be excluded.
- Subjects with 18.5 kg/m² > BMI > 24.9 kg/m² will be excluded.
- Diabetic individuals will be excluded.
- Individuals with history of gastrointestinal disease will be excluded from the study.
- Pregnant or nursing women will also be excluded.
- Individuals taking GLP-1 medications, or on weight-loss diets or restrictive eating patterns.
- Individuals suffering from dairy or gluten intolerance or allergies will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Maltodextrin
Maltodextrin increases GLP-1 from 0-60 minutes but doesn't have an extended or elevated plasma GLP-1 into 2-3 hrs post-consumption.
Participants will consume a treatment that is either entirely maltodextrin or partially maltodextrin during each of the 4 study visits.
|
75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit
Other Names:
|
|
Experimental: Low-Dose SDC
20 g of raw corn starch (SDC) + 55g of maltodextrin = 75 g total Researchers hypothesize that raw corn starch will have an extended or elevated plasma GLP-1 into 2-3 hrs post-consumption.
Participants will consume the low-dose once during one of the study visits.
|
75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit
Other Names:
Quantity of raw corn starch will vary between low, medium, and high-dose treatment arms (20, 40, 60 g respectively).
Each treatment will total 75 g using maltodextrin to account for mass difference (55, 35, 15 g respectively).
Other Names:
|
|
Experimental: Medium-Dose SDC
40 g of raw corn starch (SDC) + 35g of maltodextrin = 75 g total Researchers hypothesize that raw corn starch will have an extended or elevated plasma GLP-1 into 2-3 hrs post-consumption.
Participants will consume the medium-dose once during one of the study visits.
|
75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit
Other Names:
Quantity of raw corn starch will vary between low, medium, and high-dose treatment arms (20, 40, 60 g respectively).
Each treatment will total 75 g using maltodextrin to account for mass difference (55, 35, 15 g respectively).
Other Names:
|
|
Experimental: High-Dose SDC
60 g of raw corn starch (SDC) + 15g of maltodextrin = 75 g total Researchers hypothesize that raw corn starch will have an extended or elevated plasma GLP-1 into 2-3 hrs post-consumption.
Participants will consume the high-dose once during one of the study visits.
|
75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit
Other Names:
Quantity of raw corn starch will vary between low, medium, and high-dose treatment arms (20, 40, 60 g respectively).
Each treatment will total 75 g using maltodextrin to account for mass difference (55, 35, 15 g respectively).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total GLP-1 Secretion
Time Frame: From baseline and 15, 30, 60, 90, 120, and 180 minutes post-consumption of treatment for each participant over the course of the 4 arms.
|
To determine the impact of 20, 40, 60 g of SDC compared to a maltodextrin control on total plasma GLP-1 concentrations at baseline and 15, 30, 60, 90, 120, and 180 minutes post-consumption of SDC.
Assessed via spun blood plasma and ELISA Total GLP-1 Kits.
|
From baseline and 15, 30, 60, 90, 120, and 180 minutes post-consumption of treatment for each participant over the course of the 4 arms.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satiety
Time Frame: From baseline, 60, 120, 180 minutes and after a second meal for each participant over the course of the 4 arms.
|
Measure satiety at baseline, 60, 120, 180 minutes and after a second meal via satiety questionnaires
|
From baseline, 60, 120, 180 minutes and after a second meal for each participant over the course of the 4 arms.
|
|
Blood Glucose
Time Frame: From baseline, and 15, 30, 60, 90, 120, and 180 minutes post-consumption for each participant over the course of the 4 arms
|
To determine the impact of 20, 40, 60 g of SDC compared to a maltodextrin control on total plasma glucose concentrations at baseline and 15, 30, 60, 90, 120, and 180 minutes post-consumption of SDC.
Assessed via spun blood serum.
|
From baseline, and 15, 30, 60, 90, 120, and 180 minutes post-consumption for each participant over the course of the 4 arms
|
|
Insulin
Time Frame: From baseline, and 15, 30, 60, 90, 120, and 180 minutes post-consumption for each participant over the course of the 4 arms
|
To determine the impact of 20, 40, 60 g of SDC compared to a maltodextrin control on insulin concentrations at baseline and 15, 30, 60, 90, 120, and 180 minutes post-consumption of SDC.
Assessed via spun blood plasma.
|
From baseline, and 15, 30, 60, 90, 120, and 180 minutes post-consumption for each participant over the course of the 4 arms
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2025-00000283
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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