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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects (n=84) aged 21-50 years with a BMI of 20-29.9 kg/m2, chosen among hospital volunteers and employees from the same geographical area. A sample size of n=40 was determined from a power analysis of a within-subject design to detect a 10% difference of plasma TMAO concentration at alfa<0.05 and β =0.8. Participants were screened by the use of a blood chemistry profile, cell count, and health history questionnaire.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Trimethylamine N-oxide plasma levels	ultra high-performance liquid chromatography	September 2016 to December 2016

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2016
• Primary Completion (Actual): December 22, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 17, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 24, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 173/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No