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

NCT02838732 | Completed DMC

• 1 other identifier: 201507055MINC
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dietary Exposure

Keywords

Gut microbiota; Trimethylamine N-oxide; L-carnitine supplementation; Oral carnitine challenge test

Outcome Measures

Primary Outcomes (2)

• TMAO level

  plasma and urine TMAO concentrations of oral carnitine challenge test

  Before and 1 month after L-carnitine supplementation

• 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

Study Arms (1)

L-carnitine supplementation

EXPERIMENTAL

All participants received L-carnitine supplementation (500 mg per tablet per day, provided by GNC) for one month. Oral carnitine challenge tests and fecal sampling were conducted both before and after the intervention.

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

Interventions

L-carnitine supplementation (500 mg per tablet per day, purchased from GNC company) DIETARY_SUPPLEMENT

L-carnitine supplementation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

• Wu WK, Chen CC, Liu PY, Panyod S, Liao BY, Chen PC, Kao HL, Kuo HC, Kuo CH, Chiu THT, Chen RA, Chuang HL, Huang YT, Zou HB, Hsu CC, Chang TY, Lin CL, Ho CT, Yu HT, Sheen LY, Wu MS. Identification of TMAO-producer phenotype and host-diet-gut dysbiosis by carnitine challenge test in human and germ-free mice. Gut. 2019 Aug;68(8):1439-1449. doi: 10.1136/gutjnl-2018-317155. Epub 2018 Oct 30.

  PMID: 30377191 DERIVED

Study Officials

• Ming-Shiang Wu, MD, PhD

  National Taiwan University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants received L-carnitine supplementation (500 mg per tablet per day, GNC) for one month. Oral carnitine challenge tests and fecal sampling were conducted both before and after the intervention.

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 20, 2016
• Study Start: May 18, 2016
• Primary Completion: November 20, 2017
• Study Completion: October 7, 2019
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)