Slowly Digestible Carbohydrates for GLP-1 Secretion

Purdue University19 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Blood Glucose

Interventions

Maltodextrin (Placebo)DIETARY_SUPPLEMENT

75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit

Raw Corn StarchDIETARY_SUPPLEMENT

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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.

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 arms

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.