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

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ClinicalTrials.gov Identifier: NCT02838732
Recruitment Status : Unknown
Verified July 2016 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : July 20, 2016
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. plasma and urine TMAO level (ppm) [ Time Frame: within 6 months ]
  2. compositional analysis of gut microbiota (% of different bacteria species) [ Time Frame: within 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838732


Contacts
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Contact: Chieh-Chang Chen, MD +886-2-23123456 chiehchang.chen@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chieh-Chang Chen    +886-2-23123456    chiehchang.chen@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02838732    
Other Study ID Numbers: 201507055MINC
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases