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

Cardiovascular Risk Factor Clinical Trial

— TMED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060811
• Other study ID #: 173/16
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Mediterranean Diet
• Trimethylamine N-oxide

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