Plant-Based Meat vs Animal "Red" Meat: a Randomized Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in TMAO levels
研究概览
简要总结
To assess the changes in the circulating levels of TMAO after 1-week of beef or plant-based burger diet.
详细描述
Single-center, randomized, single-blinded cross-over trial including healthy adult participants (N=40, omnivores, aged between 25 and 65 years, and with a body mass index (BMI) between 20 and 40 kg/m2 (see participation criteria below). Participants will be randomized to either red meat (cow burger) or plant "meat" (plant-based burger). The primary outcome will be the within-group change in the TMAO levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Patients will be randomized in a 1:1 ratio. Randomization will be performed within the electronic database system at the time of enrollment using a random number generator, an approach we have used successfully in other clinical trials. The participants will be blinded to the intervention assignment (single blinded study).
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 25 years and ≤65 of age
- •BMI ≥20 Kg/m2 and ≤40 Kg/m2
- •No known kidney disease
- •No antibiotics in the previous 30 days
排除标准
- •Any person who does not meet the above criteria and/or who refuses to participate
- •Food allergies (specific ingredients contained in the patties)
结局指标
主要结局
Change in TMAO levels
时间窗: Baseline Day 6-7-20-21
Blood and urine analysis will be performed to determine TMAO levels after each intervention
次要结局
- Change in systolic and diastolic blood pressure(Baseline Day 6-7-20-21)
- Change in high-sensitivity c-reactive protein(Baseline Day 6-7-20-21)
- Change in total, LDL, and HDL cholesterol(Baseline Day 6-7-20-21)
- Change in heart rate(Baseline Day 6-7-20-21)
研究者
Abhinav Sharma
Cardiologist
McGill University Health Centre/Research Institute of the McGill University Health Centre