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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03060811
Other study ID # 173/16
Secondary ID
Status Completed
Phase N/A
First received February 14, 2017
Last updated February 24, 2017
Start date September 22, 2016
Est. completion date February 1, 2017

Study information

Verified date February 2017
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Trimethylamine N-oxide (TMAO) is a small organic compound naturally present in fish and seefood or generated by the bacterial breakdown of dietary phosphatidylcholine and carnitine-containing foods within the human gut microbiome. Elevated serum TMAO was previously reported to be associated with an elevated risk for cardiovascular events.

Aim of this study was to investigate the association between plasma levels of TMAO with the Mediterranean diet in a cohort of healthy adults.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 1, 2017
Est. primary completion date December 22, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

healthy subjects of both gender

Exclusion Criteria:

- age>65 years

- > BMI 30 kg/m2

- vegetarians

- smokers

- gastrointestinal diseases or complaints

- chronic illnesses or other metabolic diseases (including trimethylaminuria)

- abnormal blood chemistry values indicative of organ dysfunctions

- nutritional supplements, antibiotics or probiotics within 2 months of recruitment

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Federico II University

Outcome

Type Measure Description Time frame Safety issue
Primary Adherence to Mediterranean Diet by Predimed Questionnaire Validated 14-item tool of adherence to the Mediterranean diet, with three categories of adherence (=5, low adherence, 6-9, average adherence and =10 points, high adherence) September 2016 to December 2016
Primary Trimethylamine N-oxide plasma levels ultra high-performance liquid chromatography September 2016 to December 2016
Secondary cardiovascular risk metabolic syndrome parameters; Homa Index; Framingham score; ASCVD Risk Estimator September 2016 to December 2016
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