Adherence to Mediterranean Diet and Phase Angle

Completed

• Conditions: Mediterranean Diet; Phase Angle

• Registration Number: NCT02840968
• Lead Sponsor: Federico II University

Brief Summary

In this cross-sectional observational study the investigators evaluated the association between the adherence to the MD and PhA in a sample of adult population, stratified according to categories of sex, age, and BMI.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Status Verified: 2016-07
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-20
• Last Update Submitted: 2016-07-20
• Study First Posted: 2016-07-21
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1464

Inclusion Criteria

• Caucasian Subjects
• Healthy Subjects (defined as absence of a clinical condition that potentially influences fluid balance, ie, renal, endocrine, or myocardial disease, ascertained by participant questionnaire)

Exclusion Criteria

• Hypocaloric diet in the last three months or specific nutritional regimens, including vegan or vegetarian diets,
• Vitamin/mineral or antioxidant supplementation,
• Clinical conditions that could influence fluid balance, including liver or renal failure, cancer, and acute or chronic inflammatory diseases, based on a complete medical examination and laboratory investigations,
• Occasional or current of use of drugs that could influence fluid balance, including non-steroidal anti-inflammatory drugs, hormone replacement therapy, diuretics weight-loss medications, anticonvulsivants and psychotropic agents, laxative use,
• Altered thyroid hormone function tests or thyroid hormone treatment,
• Alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-V diagnostic criteria,
• Patients with implanted pacemakers or defibrillators because of the theoretical possibility of interference with the device activity due to the field of current induced by the impedance measurements,
• Subjects underweight with BMI<18.5,
• Subjects dropped out from the study since they refused to participate.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence to Mediterranean Diet by Predimed Questionnaire	January 2010 - May 2016
Phase Angle by Bioimpedance Analysis	January 2010 - May 2016