Impact of Dairy Integration Into Canadian Food Guide on Gut Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Gut epithelial permeability
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •IMC < 45
- •Waist circumference > 80 cm (Women) or 94 cm (men)
排除标准
- •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
结局指标
主要结局
Gut epithelial permeability
时间窗: This outcome will be measured on the last day (day 13) of each intervention phase.
Post-intervention lactulose/mannitol ratio by LCMS, 0-5 hours after ingestion of the non-metabolizable sugar
次要结局
- Gut inflammatory markers(Samples will be collected on days 6 and 13 of each intervention phase.)
- Perceived gut symptoms(Gastrointestinal symptoms questionnaire is administered on days 0, 4 and 13.)
- Whole gut transit time(At days 1, 4 and 11.)
研究者
Alain Veilleux
Full professor
Laval University