Impact of Dairy Integration Into Canadian Food Guide on Gut Health
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: Milk, Fermented milk, Soy beverage.
- Кому может быть актуально
- Состояния в реестре: Gut Epithelial Permeability, Gut Microbiota Composition and Diversity, Gut and Circulating Inflammatory Markers, Milk and Digestion. Базовые параметры: 40 лет — 65 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
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The primary objective is to investigate the impact of milk, fermented milk, and soy beverages, incorporated in a diet reflecting adherence to Canadian food guide recommendations on food choices on gut microbiota in middle-aged adults (45-65 years) with abdominal obesity and slightly deteriorated lipids and/or glucose profile. The study aims to discern whether the integration of soy beverages (control), milk, and fermented milk within the CFG diet contributes to distinct gut outcomes and alterations in gut health. We hypothesized that milk and fermented milk will further promote beneficial changes in gut health parameters including gut microbiota composition, trans-epithelial permeability, and inflammation, relative to soy beverages.
Подробное описание
Single-blinded crossover RCT to test the impact of integrating dairy (i.e., milk and fermented milk) into the Canadian Food Guide (CFG) diet on gut health, in fully controlled dietary settings. The trial will include mid-age women and men with abdominal obesity and slightly deteriorated metabolic profile (n=20). The trial will feature 3 controlled-feeding phases (14 days), allocated in a random order and separated by free-uncontrolled feeding washout periods (14-28 days). Each dietary intervention phase will be initiated by a Run-in full-feeding period (4 days), to standardize participants' dietary intakes, and immediately followed by one of the 3 dietary interventions (9 days) reflecting adherence to the CFG recommendation (9 days, CFG-Diet) incorporating either soy beverages (Control), milk, or non-effervescent fermented milk.
This approach was shown to be highly informative in deciphering the interaction between diet and the gut microbiota in previous work. It will be able to assess how integrating dairy (i.e., milk and fermented milk) into the Canadian Food Guide (CFG) diet promptly modulates gut health parameters (i.e. gut microbiota composition, inflammatory states, and gut permeability) in the context of obesity and metabolic complications, relative to a plant-based alternative. The fully controlled dietary setting of this study design will provide precise intakes of foods and bioactive nutrients, which will enable us to comprehensively assess the impact of dairies on gut health.
The trial will include 10 women and 10 men with abdominal obesity and slightly deteriorated metabolic profile.
Diet sequence allocation will be randomized with a sex-specific stratification. The study will be single-blinded, such as participants will not be informed of the precise nature of the diet sequence.
TRIAL INTERVENTION PHASES (3 X 14 DAYS)
During each intervention phases, all meals and foods will be provided to ensure optimal diet control. Each intervention phases will follow this sequence:
* Day 0: Initiation of the run-in full-feeding period (4 days) to standardize participants' dietary intakes. * Day 4: Baseline sampling and data collection. * Day 4: Initiation of the CFG dietary intervention (10 days) incorporating either soy beverages (Control), milk, or non-effervescent fermented milk. * Day 6: Post-intervention (+2 days) sampling and data collection. * Day 13: Post-intervention (+9 days) sampling and data collection. End of the intervention phases.
Вмешательства
- Другое Milk
Consumption of 1 cup milk 3 times per day during 9 days alongside CFG diet - Другое Fermented milk
Consumption of fermented milk 3 times per day during 9 days alongside CFG diet - Другое Soy beverage
Consumption of a soy beverage 3 times per day during 9 days alongside CFG diet
Первичные конечные точки
- Gut epithelial permeability [Срок оценки: This outcome will be measured on the last day (day 13) of each intervention phase.]
Вторичные конечные точки (3)
- Gut inflammatory markers [Срок оценки: Samples will be collected on days 6 and 13 of each intervention phase.]
- Perceived gut symptoms [Срок оценки: Gastrointestinal symptoms questionnaire is administered on days 0, 4 and 13.]
- Whole gut transit time [Срок оценки: At days 1, 4 and 11.]
Критерии участия
Критерии включения
- IMC < 45
- Waist circumference > 80 cm (Women) or 94 cm (men)
Критерии исключения
- History of diabetes (types 1 and 2), CVD, enteropathy, immune diseases or bariatric surgery
- Cancer (diagnostic and/or treatment) during the last 5 years
- Antibiotic consumption during the last 3 months
- Active smoking or cannabis consumption
- Lactose intolerance or allergy, any allergies to foods given in the intervention phases
- Irregular defecation patterns
- Pregnancy/lactation
- Inability to speak French
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
- Тройное слепое
- Основная цель
- Фундаментальное исследование
Центры проведения
Канада · 1 центр
- Institute of Nutrition and Functional Foods (INAF) — Québec
Идентификаторы
NCT: NCT07257913 · 2024-569