NCT02840968CompletedNot Applicable
Influence of Mediterranean Diet on Phase Angle in a Sample of Adult Population: Results of a Pilot Study
Federico II University0 sites1,464 target enrollmentStarted: January 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,464
- Primary Endpoint
- Adherence to Mediterranean Diet by Predimed Questionnaire
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Adherence to Mediterranean Diet by Predimed Questionnaire
Time Frame: January 2010 - May 2016
Phase Angle by Bioimpedance Analysis
Time Frame: January 2010 - May 2016
Secondary Outcomes
No secondary outcomes reported
Investigators
Prof. Silvia Savastano
Researcher/Adjunct Professor
Federico II University
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