Whey Protein Ingestion and Glucose Control in Pre- and Post Diabetic Individuals
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Whey Protein Isolate Crossover, Placebo.
- Кому может быть актуально
- Состояния в реестре: Prediabetes / Type 2 Diabetes. Базовые параметры: 50 лет — 70 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
To examine the effects of twice daily whey protein consumption on blood glucose and insulin in pre-diabetic and diabetic individuals
Подробное описание
Protein consumption in the morning has been shown to reduce appetite and caloric intake (19). In addition, premeal whey consumption reduces post prandial blood glucose, reduces gastric emptying rate, and increases peak blood insulin (10). Thus, it is proposed that ingestion of whey protein within 1hr of waking (and prior to breakfast) and 30 minutes prior to dinner will be more effective in suppressing appetite, carbohydrate intake, and glucose AUC. Ingestion upon waking will mitigate the cortisol-induced drive for carbohydrate intake. Ingestion prior to dinner, the most frequently consumed and largest meal in America (20), will reduce food intake, post meal blood glucose, and insulin area under the curve (21).
Specific Aims
1. Determine the effect of WP ingestion within 1hr of waking and prior to breakfast, and 30min prior to dinner, on appetite suppression, carbohydrate and caloric intake, and 24hr glucose AUC over 7d in pre-diabetic (A1C 5.7%-6.4%) and diabetic (A1C 6.5%-7.5%) individuals. 2. Determine the effect of WP ingestion within 1hr of waking and 30min prior to dinner on changes in OGTT, Matsuda index, and whole-body protein balance (compared to control) before and after 7d of WP consumption in pre-diabetic and diabetic individuals. 3. Determine outcome differences between pre-diabetic and diabetic individuals.
Вмешательства
- Пищевая добавка Whey Protein Isolate Crossover
This crossover intervention includes 1 week of whey protein isolate supplementation and 1 week of placebo supplementation. - Пищевая добавка Placebo
1 week of Non-whey protein Placebo supplement
Первичные конечные точки
- Whole body protein turnover [Срок оценки: 7 days]
- Oral Glucose Tolerance Test [Срок оценки: 7 days]
- Blood glucose [Срок оценки: 7 days]
Вторичные конечные точки (2)
- Composite Appetite Scale [Срок оценки: 7 days]
- Dietary Intake Log [Срок оценки: 7 days]
Критерии участия
Критерии включения
- Males and females ages 50-70 years.
- Body mass index between 25-45 kg/m2
- Capable of providing informed consent.
- COVID-19 negative and/or asymptomatic.
- Willing to abstain from drinking alcohol or consuming marijuana and CBD products during the 7-day study meal period on two occasions.
- HbA1c: 5.7-6.4% or 6.5% to 7.5% or fasting glucose ≥100 mg/dL
Критерии исключения
- Subject who does not/will not eat dairy protein sources.
- Subjects taking exogenous insulin injections or GLP /GIP injections or other appetite suppressants.
- Unwilling to keep a detailed 7 day food journal on two occasions
- Unwilling to wear a CGM for 7 days on two occasions and share the data with the research team.
- Lactose intolerance.
- Hemoglobin <10g/dL at screening.
- History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
- History of gastrointestinal bypass/reduction surgery.
- Pregnant or lactating individuals.
- History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease)
- Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
- Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).
- Unwilling to avoid using protein or amino-acid supplements during participation.
- Unwilling to fast overnight.
- Any medical condition or medication that the PI or clinical study staff finds contradictory to this study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Тройное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- University of Arkansas for Medical Sciences — Little Rock
Идентификаторы
NCT: NCT06694155 · 297495