Slowly Digestible Carbohydrates for GLP-1 Secretion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorPurdue University
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy population
BMI between 18.5 and 24.9 kg/m2
Adults 18 - 45 years old
Men or women
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Maltodextrin (Placebo)
Dietary supplement75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit
Raw Corn Starch
Dietary supplementQuantity 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).
Treatment groups
19 Participants
are divided into 4 treatment groupsGroup A: MaltodextrinPlacebo comparator 1 intervention
Group B: Low-Dose SDCExperimental treatment 2 interventions
Group C: Medium-Dose SDCExperimental treatment 2 interventions
Group D: High-Dose SDCExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Total GLP-1 Secretion
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.
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.Secondary outcomes
1
Satiety
Measure satiety at baseline, 60, 120, 180 minutes and after a second meal via satiety questionnaires
Time frame
From baseline, 60, 120, 180 minutes and after a second meal for each participant over the course of the 4 arms.2
Blood Glucose
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.
Time frame
From baseline, and 15, 30, 60, 90, 120, and 180 minutes post-consumption for each participant over the course of the 4 arms3
Insulin
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.
Time frame
From baseline, and 15, 30, 60, 90, 120, and 180 minutes post-consumption for each participant over the course of the 4 armsSponsors and contacts
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Source ClinicalTrials.gov