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

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.

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Key information

Conditions

Mediterranean Diet Cardiovascular Risk Factor Trimethylamine N-oxide

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Adherence to Mediterranean Diet by Predimed Questionnaire

Time frame: 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

Time frame: September 2016 to December 2016

ultra high-performance liquid chromatography

Secondary outcomes

cardiovascular risk

Time frame: September 2016 to December 2016

metabolic syndrome parameters; Homa Index; Framingham score; ASCVD Risk Estimator

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Acronym: TMED

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2017
First posted: Feb 23, 2017
Registry last updated: Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed