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

NCT03060811 | Completed

• 1 other identifier: 173/16
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• cardiovascular risk

  September 2016 to December 2016

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• healthy subjects of both gender

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher/Adjunct Professor

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 23, 2017
• Study Start: September 22, 2016
• Primary Completion: December 22, 2016
• Study Completion: February 1, 2017
• Last Updated: February 27, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share