Skip to main content
OpenTrials
Completed

NCT Number: NCT06175260

Investigation on the Efficacy of Oral Carnitine Challenge Test Based on a Gut Microbiota Functional Test

This study seeks to enlist healthy volunteers to form a validation cohort. The purpose is to confirm the observed correlations between the gut microbiome and the capacity to produce trimethylamine N-oxide (TMAO), which will be assessed using the oral carnitine challenge test (OCCT).

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

Carnitine, a nutrient widely found in meat, can promote the use of fatty acids by mitochondria to produce energy in the human body. It was previously thought to be beneficial in helping the body consume fat for energy and might be helpful for muscle training or weight loss. However, some human populations have harmful bacteria in their intestines that compete with the body for the use of carnitine. These bacteria metabolize carnitine to produce potentially harmful Trimethylamine N-oxide (TMAO). This might be one of the reasons why long-term consumption of red meat, which is rich in carnitine, is associated with a higher risk of cardiovascular disease. Therefore, understanding the functional state of one's gut microbiota and whether it is suitable to consume foods rich in carnitine can greatly aid in long-term dietary and health planning. In recent years, we have established an oral carnitine challenge test that (OCCT) can distinguish whether the intestinal bacteria in a subject produce a large amount of TMAO in the body. This was published in the Gut journal in 2019 and is expected to provide dietary or nutritional supplement recommendations for personalized nutrition for the test subjects. However, the value of the carnitine challenge test in distinguishing between high TMAO producers and low TMAO producers, and whether it can serve as an effective reference for whether a subject is suitable to consume large amounts of meat or take carnitine supplements, still needs further experimental verification. This study seeks to enlist healthy volunteers to form a validation cohort. The purpose is to confirm the observed correlations between the gut microbiome and the capacity to produce TMAO, which will be assessed using the OCCT.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults aged 20 and above who are willing to participate in the trial.

Exclusion criteria

  • Under the age of 20
  • History of gastrointestinal surgery
  • History of malignant tumors
  • Those who have used antibiotics, probiotics, or carnitine supplements within the past month will be excluded
  • Liver cirrhosis
  • End-stage kidney disease

Treatment and study plan

oral carnitine challenge test

Diagnostic Test

Urine samples will be collected to quantify trimethylamine N-oxide (TMAO) levels at four time points: before, and 24, 48, and 72 hours after the oral administration of 1500 mg of L-carnitine.

Primary outcomes

  1. Trimethylamine N-oxide (TMAO) production capacity measured by oral carnitine challenge test (OCCT)

    Time frame: at enrollment

    The area under the curve of TMAO levels under OCCT

Secondary outcomes

  1. Correlations between the gut microbiome and the capacity to produce TMAO

    Time frame: at enrollment

    The gut microbiome indicated microbial genes and taxonomies measured by shotgun metagenome sequencing whereas TMAO producing capacity was measured by OCCT.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Dec 18, 2023
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.