Adherence to Mediterranean Diet and Phase Angle

Mediterranean Diet Clinical Trial

Official title:

Influence of Mediterranean Diet on Phase Angle in a Sample of Adult Population: Results of a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02840968
• Other study ID #: 239/11
• Status: Completed
• Phase: N/A
• First received: July 12, 2016
• Last updated: July 20, 2016
• Start date: January 2010
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1464
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Mediterranean Diet
• Phase Angle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to Mediterranean Diet by Predimed Questionnaire		January 2010 - May 2016	No
Primary	Phase Angle by Bioimpedance Analysis		January 2010 - May 2016	No