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

Dietary Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838732
• Other study ID #: 201507055MINC
• Status: Completed
• Phase: N/A
• Start date: May 18, 2016
• Est. completion date: October 7, 2019

Study information

• Verified date: December 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 7, 2019
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy subjects aged 20 to 65 years old

• no usage of antibiotics within one month

• no use of carnitine supplement within one month

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dietary Exposure

Intervention

Dietary Supplement:
• L-carnitine supplementation (500 mg per tablet per day, purchased from GNC company)

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TMAO level	plasma and urine TMAO concentrations of oral carnitine challenge test	Before and 1 month after L-carnitine supplementation
Primary	Compositional and functional alterations of gut microbiota	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).	Before and 1 month after L-carnitine supplementation