Идёт набор NCT05783466
Dairy Lipids and Cardiometabolic Risk
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: Low-fat dairy products, Whole-fat dairy products, Milk polar lipid enriched whole-fat dairy products.
- Кому может быть актуально
- Состояния в реестре: Morbid Obesity. Базовые параметры: 18 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
- Франция
- 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 →
Официальное название
Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity
Обзор
It is a randomized parallel arm intervention study in adults with severe obesity. The objective is to demonstrate that within a dietary handling for weight loss, the daily ingestion during 3 months of whole dairy products enriched with milk polar lipids or whole dairy products decreases to a greater extent fasting plasma apolipoprotein B concentrations than the daily ingestion of low-fat dairy products (control group). Metabolic parameters will be assessed before and after the 3-month intervention, both at fasting and in postprandial period after the consumption of standardized meals.
Вмешательства
- Другое Low-fat dairy products
3-month intervention - Другое Whole-fat dairy products
3-month intervention - Другое Milk polar lipid enriched whole-fat dairy products
3-month intervention
Первичные конечные точки
- Total plasma apolipoprotein B concentration [Срок оценки: day 0 and day 90]
Вторичные конечные точки (12)
- Changes in weight [Срок оценки: day 0 and day 90]
- Anthropometric measurements 2 [Срок оценки: day 0 and day 90]
- Body mass composition measurements [Срок оценки: day 0 and day 90]
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods [Срок оценки: day 0 and day 90 for fasting and postprandial measurements. • For postprandial measurements: times 60 minutes-120 minutes -180 minutes -240 minutes -270 minutes -300 minutes -360 minutes]
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 2 [Срок оценки: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -180 minutes -240 minutes -270 minutes -300 minutes.]
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 3 [Срок оценки: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: time 360 minutes.]
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 4 [Срок оценки: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: time 360 minutes.]
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 5 [Срок оценки: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes -300 minutes.]
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 6 [Срок оценки: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes -300 minutes - 360 minutes]
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 7 [Срок оценки: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements:times 360 minutes.]
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 8 [Срок оценки: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes]
- Glucose concentrations after 3-month intervention, measured using standard laboratory methods [Срок оценки: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes]
Критерии участия
Критерии включения
- Men and women between 18-70 years
- Body Mass Index (BMI) between 35 and 60 kg/m2 inclusive
- Stable body weight (weight change +/- 5 % for 3 months prior to screening)
- Consumption of at least 1 serving/day of dairy products made from cow's milk
- Informed consent
Критерии исключения
- History of bariatric or digestive surgery or disease interfering with main outcomes
- Drinking more than 3 glasses of alcohol per day (>30g/day)
- Pregnancy, parturiency or breastfeeding
- Food allergies or intolerance to dairy products
- Dietary restriction (vegetarian or lactovegetarian) or high protein diet
- Use of dietary supplements
- Treated with lipid lowering drugs (fibrates, statins, anti-PCSK9, ezetimibe, cholestyramine) within the last 6 weeks before study entry
- Treated with insulin, GLP-1 analogs, acarbose, corticoids, beta-blockers.
- Medications interfering with intestinal microbiota (beta-lactamines within 3 months before the study or laxatives)
- Smoking ≥ 5 cigarettes/day during the past 6 months.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Франция · 2 центра
- Centre de Recherche en Nutrition Humaine Rhône-Alpes — Pierre-Bénite
- Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition — Pierre-Bénite
Идентификаторы
NCT: NCT05783466 · 69HCL22_0461 · 2022-A02415-38