Slowly Digestible Carbohydrates for GLP-1 Secretion

Обзор

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

Вмешательства

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

Первичные конечные точки

• Total GLP-1 Secretion [Срок оценки: 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.]

Вторичные конечные точки (3)

• Satiety [Срок оценки: From baseline, 60, 120, 180 minutes and after a second meal for each participant over the course of the 4 arms.]
• Blood Glucose [Срок оценки: From baseline, and 15, 30, 60, 90, 120, and 180 minutes post-consumption for each participant over the course of the 4 arms]
• Insulin [Срок оценки: From baseline, and 15, 30, 60, 90, 120, and 180 minutes post-consumption for each participant over the course of the 4 arms]

Критерии участия

Критерии включения

• 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%

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Clinical Research Center at Purdue University — West Lafayette

Идентификаторы

NCT: NCT07572513 · IRB-2025-00000283

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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