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Clinical Trials/NCT02840968
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

Sponsor
Federico II University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Silvia Savastano

Researcher/Adjunct Professor

Federico II University

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