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Recruiting NCT07572513

Slowly Digestible Carbohydrates for GLP-1 Secretion

No phase Interventional Blood Glucose GLP-1 Satiety Second Meal Intake

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Maltodextrin (Placebo), Raw Corn Starch.
Who it may be relevant to
Registry conditions: Blood Glucose, GLP-1, Satiety, Second Meal Intake. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

Interventions

  • Dietary supplement Maltodextrin (Placebo)
    75 g of maltodextrin diluted in 200 mL of water, taken once at a study visit
  • 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).

Primary outcome measures

  • 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.]
Secondary outcome measures (3)
  • Satiety [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 [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 [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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Clinical Research Center at Purdue University — West Lafayette

Identifiers

NCT: NCT07572513 · IRB-2025-00000283

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗