Blood Glucose, GLP-1, Healthy Participant Study, Satiety, Second Meal Intake
Conditions
Keywords
GLP-1, Slowly-Digestible Starch, Ileal-Digesting Starch, Dietary Starch, Satiety, Starch, raw corn starch, Blood Glucose
Brief summary
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
Interventions
DIETARY_SUPPLEMENTMaltodextrin (Placebo)
75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit
DIETARY_SUPPLEMENTRaw Corn Starch
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).
Sponsors
Purdue University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized, acute, crossover, double-blinded, clinical trial (RCT)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy population 2. BMI between 18.5 and 24.9 kg/m2 3. Adults 18 - 45 years old 4. Men or women 5. Able to read/speak English 6. Fasting blood glucose levels ≤100 mg/dL 7. HbA1c ≤ 5.7%
Exclusion criteria
1. Participants with 18 \> Years of Age \> 45 will be excluded. 2. Subjects with 18.5 kg/m² \> BMI \> 24.9 kg/m² will be excluded. 3. Diabetic individuals will be excluded. 4. Individuals with history of gastrointestinal disease will be excluded from the study. 5. Pregnant or nursing women will also be excluded. 6. Individuals taking GLP-1 medications, or on weight-loss diets or restrictive eating patterns. 7. Individuals suffering from dairy or gluten intolerance or allergies will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total GLP-1 Secretion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satiety | 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 |
| Blood Glucose | 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. |
| Insulin | 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. |
Countries
United States
Contacts
CONTACTBruce R Hamaker, Ph.D.
CONTACTErica de Jong, B.s.
Outcome results
None listed