Investigation on the Effect of Carnitine Supplement on Gut Microbiota and TMAO Plasma Concentration

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02838732
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

In this project, the investigators aim to investigate if daily carnitine supplementation could induce TMAO productivity of vegetarian gut microbiota and through which the TMAO producers might be disclosed.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis	Dietary Supplement: L-carnitine	N/A

Detailed Description

Recently, plasma trimethylamine N-oxide (TMAO) level has been proved to be a strong and independent risk factor of cardiovascular disease. TMAO is formed through interaction between gut microflora and the ingested carnitine from food. Studies have shown that plasma TMAO concentration and TMAO productivity of gut microbiota in vegetarians are significantly lower than omnivores. This is probably due to a lack of carnitine in the diet of vegetarians. Therefore, it is worth investigating whether carnitine supplementation could induce TMAO productivity of human gut microbiota as well as to reveal TMAO producers from gut microflora. Therefore, the investigators plan to recruit 20 vegetarian and 10 omnivore volunteers to receive carnitine supplement for weeks, and study the change of plasma TMAO and gut microbiota. The plasma TMAO concentration will be measured by the LC-MS, and the gut microbiota composition will be analyzed by the next generation sequencing. Through bioinformatics analysis, the potential TMAO-producing bacteria might be discovered. The change of plasma TMAO level and gut microbiota composition after carnitine supplementation can provide more understanding on the relationship between carnitine supplement, TMAO and gut microflora.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Investigation on the Effect of Carnitine Supplement on Gut Microbiota and TMAO Plasma Concentration
• Study Start Date: May 1, 2016
• Anticipated Primary Completion Date: Sep 1, 2016
• Anticipated Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vegetarian oral L-carnitine for one month	Dietary Supplement: L-carnitine
Sham Comparator: omnivore oral L-carnitine for one month	Dietary Supplement: L-carnitine

Outcome Measures

Primary Outcome Measures

1. plasma and urine TMAO level (ppm) [within 6 months]

2. compositional analysis of gut microbiota (% of different bacteria species) [within 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• no usage of antibiotics and carnitine supplement within one month

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital, National Taiwan University Hospital, National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT02838732
• Other Study ID Numbers: 201507055MINC
• First Posted: Jul 20, 2016
• Last Update Posted: Jul 20, 2016
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Atherosclerosis

Study Results

No Results Posted as of Jul 20, 2016