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

NCT ID: NCT03060811

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-22
• Study Completion Date: 2017-02-01

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.

Conditions

Mediterranean Diet; Trimethylamine N-oxide; Cardiovascular Risk Factor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Prof. Silvia Savastano

Researcher/Adjunct Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

173/16

Identifier Type: -

Identifier Source: org_study_id