Mediterranean Diet, Trimethylamine N-oxide (TMAO) and Anti-oxidants in Healthy Adults

Completed

• Conditions: Mediterranean Diet; Cardiovascular Risk Factor; Trimethylamine N-oxide

• Registration Number: NCT03060811
• Lead Sponsor: Federico II University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-22
• Primary Completion: 2016-12-22
• Status Verified: 2017-02
• Study Completion: 2017-02-01
• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-17
• Study First Posted: 2017-02-23
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence to Mediterranean Diet by Predimed Questionnaire	September 2016 to December 2016	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)
Trimethylamine N-oxide plasma levels	September 2016 to December 2016	ultra high-performance liquid chromatography

Secondary Outcome Measures

Name	Time	Method
cardiovascular risk	September 2016 to December 2016	metabolic syndrome parameters; Homa Index; Framingham score; ASCVD Risk Estimator