Investigation on the Effect of Carnitine Supplement on Gut Microbiota and TMAO Plasma Concentration
Primary Purpose
Atherosclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
L-carnitine
Sponsored by
About this trial
This is an interventional basic science trial for Atherosclerosis
Eligibility 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
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
vegetarian
omnivore
Arm Description
oral L-carnitine for one month
oral L-carnitine for one month
Outcomes
Primary Outcome Measures
plasma and urine TMAO level (ppm)
compositional analysis of gut microbiota (% of different bacteria species)
Secondary Outcome Measures
Full Information
NCT ID
NCT02838732
First Posted
July 8, 2016
Last Updated
July 17, 2016
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02838732
Brief Title
Investigation on the Effect of Carnitine Supplement on Gut Microbiota and TMAO Plasma Concentration
Official Title
Investigation on the Effect of Carnitine Supplement on Gut Microbiota and TMAO Plasma Concentration
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vegetarian
Arm Type
Experimental
Arm Description
oral L-carnitine for one month
Arm Title
omnivore
Arm Type
Sham Comparator
Arm Description
oral L-carnitine for one month
Intervention Type
Dietary Supplement
Intervention Name(s)
L-carnitine
Primary Outcome Measure Information:
Title
plasma and urine TMAO level (ppm)
Time Frame
within 6 months
Title
compositional analysis of gut microbiota (% of different bacteria species)
Time Frame
within 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chieh-Chang Chen, MD
Phone
+886-2-23123456
Email
chiehchang.chen@gmail.com
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chieh-Chang Chen
Phone
+886-2-23123456
Email
chiehchang.chen@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30377191
Citation
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.
Results Reference
derived
Learn more about this trial
Investigation on the Effect of Carnitine Supplement on Gut Microbiota and TMAO Plasma Concentration
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