Evaluation of Microbial-derived TMAO Production From Carnitine Intake by Testing Fecal Gbu Gene
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Fecal gbuB gene abundance measured by qPCR
研究概览
简要总结
The risk of cardiovascular diseases from red meat consumption varies among individuals due to variations in gut microbiota. L-carnitine in red meat can be converted to TMAO in the body by certain bacteria. Not everyone experiences a significant increase in TMAO levels after consuming carnitine. Gut microbiota differences are observed between high and low TMAO producers. The presence of the gbu gene in gut microbiota is linked to TMAO production. This clinical research aims to determine if the gbu gene can predict TMAO levels after dietary carnitine intake.
详细描述
The risk of developing cardiovascular diseases due to the consumption of red meat varies among individuals, and this may be attributed to differences in the composition and function of gut microbiota. Studies have found that red meat, rich in L-carnitine, may be metabolized by certain anaerobic bacteria in the intestines to produce trimethylamine N-oxide (TMAO) in the human body. Previous research utilizing the oral carnitine challenge test (OCCT) revealed that not everyone experiences a significant increase in blood TMAO levels after consuming carnitine. Moreover, individuals with high TMAO production and low TMAO production showed distinct differences in their gut microbiota.
Furthermore, we have discovered a significant correlation between the abundance of the gbu gene in gut microbiota and the production of TMAO in response to dietary carnitine intake. Therefore, through the design of clinical research, we aim to investigate and assess whether the abundance of the gbu gene in gut microbiota can predict the levels of TMAO produced in the human body under dietary carnitine intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult with age between 18 to 70
- •Must be able to swallow tablets
排除标准
- •Antibiotics use within one month
- •L-carnitine supplement use within one month
- •Chronic diarrhea
- •Myasthenia gravis
- •Diabetes mellitus
- •Parathyroid disorders
- •Chronic kidney disease
- •Severe anemia
- •Cardiovascular diseases.
研究组 & 干预措施
L-Carnitine supplementation
Participants are required to take a capsule containing 500mg L-carnitine/day continuous for 7-10 days. During the intervention, participants are asked to collect urine sample and dietary record each day. Blood and fecal samples will be collected before and after the intervention. Each participant needs to complete a food frequency questionnaire.
干预措施: L-carnitine (Dietary Supplement)
结局指标
主要结局
Fecal gbuB gene abundance measured by qPCR
时间窗: up to 7-10 days
Blood TMAO level measured by LC-MS/MS
时间窗: up to 7-10 days
Urine TMAO level measured by LC-MS/MS
时间窗: up to 7-10 days
次要结局
- Carnitine intake measured by 24hr dietary record(up to 7-10 days)
- Gut microbiome profiles measured by shotgun metagenome sequencing(up to 7-10 days)