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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03060811

Acronym

TMED

Enrollment

Registered

2017-02-23

Start date

2016-09-22

Completion date

2017-02-01

Last updated

2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor, Mediterranean Diet, Trimethylamine N-oxide

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
cardiovascular risk	September 2016 to December 2016	metabolic syndrome parameters; Homa Index; Framingham score; ASCVD Risk Estimator

Outcome results