Health Effects of Grain Foods in Adults
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: High Whole Grain, Low Sugar, Low Whole Grain, Low Sugar, High Whole Grain, High Sugar, Low Whole Grain, High Sugar.
- Кому может быть актуально
- Состояния в реестре: High Whole Grain and Low Sugar, Medium Whole Grain and Low Sugar, Low Whole Grain and Low Sugar, Low Whole Grain and High Sugar. Базовые параметры: 21 лет — 60 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
This study will assess the effects of eating whole grain foods versus refined grain foods with different amounts of added sugar. It is hypothesized that a diet including grain products will have beneficial effects on taste hedonics, appetite, food/energy intake, body weight, blood pressure, acute and chronic glycemia and acute and chronic lipemia compared to customary diets controlling for added sugars, saturated fats and sodium.
Подробное описание
This 16-week, randomized, controlled, parallel-arm, clinical trial will assess the effects of consuming four different categories of grain foods on taste hedonics, appetite, food/energy intake, body weight, and blood pressure as well as acute and longer-term glycemia and lipemia. It will also examine the effects of foods varying in grain/carbohydrate composition on the microbiome and microbiota functionality. One hundred and twenty adults will be recruited and randomly assigned to one of four intervention groups. These groups will be defined by the diets they are prescribed. All will be prescribed diets containing approximately 50%; 35% and 15% energy from carbohydrate, fat and protein, respectively. Grain foods will comprise 50% of the carbohydrate component (i.e., 25% of total energy). The grain foods will be assigned to one of four categories based on whole grain content and concentrations of added sugars. The grain foods meeting these criteria will have the following composition:
Group 1 - High Whole Grain, Low Sugar 6 servings of whole grain and \<13% energy from added sugars.
Group 2 - Low Whole Grain, Low Sugar 3 servings of whole grain and \<13% energy from added sugars.
Group 3 - High Whole Grain, High Sugar 6 servings of whole grain and \>13% energy from added sugars.
Group 4 - Low Whole Grain, High Sugar 3 servings of whole grain and \>13% energy from added sugars.
Detailed Study Design
The study measures and timing are outlined in the following table:
Screening Week 1 Baseline Week 2 Week 5 Week 8 Week 11 Week 14 Fasting Blood X X X XX MTT X X X Weight X X X X X X Body Composition X X CGM X X X Intake X Hedonics (palatability) X X X Appetite X X X Activity X X X Blood Pressure X X X X X X Microbiota X X X X X Compliance X X X X X MTT = Meal Tolerance Test; DXA= Dual-energy X-ray Absorptiometry; CGM=Continuous glucose monitoring
Вмешательства
- Другое High Whole Grain, Low Sugar
6 servings of whole grain and \<13% energy from added sugars. - Другое Low Whole Grain, Low Sugar
3 servings of whole grain and \<13% energy from added sugars. - Другое High Whole Grain, High Sugar
6 servings of whole grain and \>13% energy from added sugars. - Другое Low Whole Grain, High Sugar
3 servings of whole grain and \>13% energy from added sugars.
Первичные конечные точки
- Glycemia [Срок оценки: 12 weeks]
Вторичные конечные точки (6)
- Appetite [Срок оценки: 12 weeks]
- Taste Hedonics [Срок оценки: 12 weeks]
- Energy Intake [Срок оценки: 12 weeks]
- Body Weight [Срок оценки: 12 weeks]
- Systolic and Diastolic Blood Pressure [Срок оценки: 12 weeks]
- Lipemia [Срок оценки: 12 weeks]
Критерии участия
Критерии включения
- male and female; 21 to 60 years old; Hemoglobin A1c concentration between 5.7 and 6.4%
- Prefer no use of medications, but if on medication, must have been on a stable dose for 3 months and plan to remain at the same dose for the duration of the trial.
- low customary intake of whole grain foods (less than 2 servings per day) and high energy from added sugar (greater than 10% energy).
Критерии исключения
- Grain or dairy sensitivities or allergies or celiac disease; sensitivity or allergy to other foods that would result in refusal to eat a class of foods.
- smoker
- intended weight loss or gain during the study period; intended change of activity level during the study period
- use of blood thinners
- prior gastrointestinal surgery.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Фундаментальное исследование
Центры проведения
США · 1 центр
- Purdue University — West Lafayette
Идентификаторы
NCT: NCT06339879 · IRB-2023-1071