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Purpose

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

Conditions

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Randomized, acute, crossover, double-blinded, clinical trial (RCT)
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Dietary Supplement: Maltodextrin (Placebo)
    75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit
    Other names:
    • Control
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.
  • Dietary Supplement: Maltodextrin (Placebo)
    75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit
    Other names:
    • Control
  • Dietary Supplement: Raw 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).
    Other names:
    • Slowly-Digestible Carbohydrate
    • Ileal-Digesting Starch
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.
  • Dietary Supplement: Maltodextrin (Placebo)
    75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit
    Other names:
    • Control
  • Dietary Supplement: Raw 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).
    Other names:
    • Slowly-Digestible Carbohydrate
    • Ileal-Digesting Starch
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.
  • Dietary Supplement: Maltodextrin (Placebo)
    75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit
    Other names:
    • Control
  • Dietary Supplement: Raw 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).
    Other names:
    • Slowly-Digestible Carbohydrate
    • Ileal-Digesting Starch

Recruiting Locations

Clinical Research Center at Purdue University
West Lafayette, Indiana 47907
Contact:
Cheryl Armstrong, Ph.D.
765-496-6275
armstroc@purdue.edu

More Details

Status
Recruiting
Sponsor
Purdue University

Study Contact

Bruce R Hamaker, Ph.D.
765-494-5668
hamakerb@purdue.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.