The Effect of Pork and Chicken Diets on Gut Microbiota Composition and Metabolites Related to Cardiometabolic Wellbeing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Microbiota-dependent TMAO-response, measured as serum concentration
研究概览
简要总结
The project will characterize human gut microbiome response to two different diets and the possible physiological and biochemical implications of such response on cardiometabolic risk factors. The study will use controlled-feeding, systems-biology, metagenomic, and metabolomic approaches to examine American dietary patterns.
详细描述
The study will use controlled-feeding, systems-biology, metagenomic, and metabolomic approaches to examine American dietary patterns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •generally good health status based on one routine physical in the past 15 months, current health status
- •normal HbA1C, weigh 110 lb or more
- •Age 50 years or more, generally healthy, all races and both sexes
- •generally practicing a meat-based dietary pattern, do not have any special dietary requirement, and
- •willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.
排除标准
- •medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use
- •Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight.
- •impaired kidney functions
- •Active history of cancer, diabetes, heart, liver, and kidney diseases
- •major gastrointestinal disorders in the past 3 months
- •history of heart attacks or stroke
- •Unable to meet in-person visit requirements for dining, picking up meals, and tests
- •Any mental health condition that would affect the ability to provide written informed consent.
- •If they had not had a routine health checkup during the 12 months prior to recruitment.
- •If they were unwilling to abstain from taking nutritional supplements, alcohol, non-study foods, and beverage during the study period.
研究组 & 干预措施
Pork
Standard American Diet with meat source: lean pork. Diet adheres to 2015-2020 Guidelines for Americans.
干预措施: diet (Other)
Poultry
Standard American Diet with meat source: chicken. Diet adheres to 2015-2020 Guidelines for Americans.
干预措施: diet (Other)
结局指标
主要结局
Microbiota-dependent TMAO-response, measured as serum concentration
时间窗: 10 days per diet arm
targeted sequencing
Serum concentration of biogenic amine metabolites
时间窗: 10 days per diet arm
Metabolomics
次要结局
未报告次要终点
研究者
Moul Dey
Professor
South Dakota State University