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临床试验/NCT02838732
NCT02838732已完成不适用

Investigation on the Effect of Carnitine Supplement on Gut Microbiota and TMAO Production Capacity

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2016年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Compositional and functional alterations of gut microbiota

研究概览

简要总结

In this project, the investigators aim to explore the impact of dietary L-carnitine supplementation on the TMAO production capacity of gut microbiota.

详细描述

Recent studies have established plasma trimethylamine N-oxide (TMAO) levels as a strong, independent risk factor for cardiovascular disease. TMAO is produced by the interaction between gut microflora and ingested L-carnitine from food. Research indicates that both plasma TMAO concentration and the TMAO production capacity of gut microbiota in vegetarians are significantly lower than in omnivores, likely due to the reduced L-carnitine intake in vegetarian diets. This study aims to explore the impact of L-carnitine supplementation on the TMAO production capacity of human gut microbiota and to identify TMAO-producing bacteria within the gut microflora. The study plans to recruit both omnivore and vegetarian volunteers to undergo a one-month L-carnitine supplementation, followed by an evaluation of changes in TMAO production using an oral L-carnitine challenge test, along with gut microbiota assessment. TMAO concentration will be measured using LC-MS/MS, and gut microbiome analysis will be conducted through shotgun metagenome sequencing. Bioinformatic analysis may reveal potential TMAO-producing bacteria. Understanding the changes in TMAO production and gut microbiota composition post-L-carnitine supplementation may enhance our knowledge of the interplay between L-carnitine supplements, TMAO, and gut microflora.

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
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects aged 20 to 65 years old
  • no usage of antibiotics within one month
  • no use of carnitine supplement within one month

排除标准

  • having serious GI disorder
  • medical history of myasthenia gravis
  • history of diabetes,
  • history of hyperparathyroidism,
  • history of chronic kidney disease
  • history of epilepsy
  • history of severe anemia

结局指标

主要结局

Compositional and functional alterations of gut microbiota

时间窗: Before and 1 month after L-carnitine supplementation

The compositional and functional changes of gut microbiota will be evaluated by shotgun metagenome sequencing. Taxonomy will be calculated as relative abundance of species-level genome bins (SGBs) and specific bacteria genes will be quantified as Reads Per Kilobase per Million (RPKM).

TMAO level

时间窗: Before and 1 month after L-carnitine supplementation

plasma and urine TMAO concentrations of oral carnitine challenge test

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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