Mediterranean DietNCT02840968
Adherence to Mediterranean Diet and Phase Angle
An observational study of Mediterranean Diet and Phase Angle, run by Federico II University.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Mediterranean Diet, Phase Angle
- How many people
- 1,464 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Recruitment strategies included attendance at the outpatient obesity clinics at the investigators Department or the outdoor hospital of the Campus Salute. The study is part of a large database started in 2010 to investigate the health status of the general population of Campania Region as analysed by the free consultation, visit, and diagnostics for people coming to the outdoor hospital held in different public squares of the investigators Region.
Who may be able to join
- 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)
Who cannot join
- 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,
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- 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.
About this study
Official title: Influence of Mediterranean Diet on Phase Angle in a Sample of Adult Population: Results of a Pilot Study
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.
- Conditions
- Mediterranean Diet, Phase Angle
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Mediterranean Diet by Predimed Questionnaire
Measured: January 2010 - May 2016
Phase Angle by Bioimpedance Analysis
Measured: January 2010 - May 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJan 2010
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediterranean DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,464 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Silvia Savastano, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840968
- Sponsor's protocol ID
- 239/11
- Status last verified
- Jul 2016
- First submitted
- 12 Jul 2016
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Mediterranean Diet on Phase Angle in a Sample of Adult Population: Results of a Pilot Study
- ClinicalTrials.gov ID
- NCT02840968
- Acronym / sponsor ID
- 239/11
- Conditions
- Mediterranean Diet, Phase Angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,464 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Recruitment strategies included attendance at the outpatient obesity clinics at the investigators Department or the outdoor hospital of the Campus Salute. The study is part of a large database started in 2010 to investigate the health status of the general population of Campania Region as analysed by the free consultation, visit, and diagnostics for people coming to the outdoor hospital held in different public squares of the investigators Region.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence to Mediterranean Diet by Predimed Questionnaire
Time frame: January 2010 - May 2016
Phase Angle by Bioimpedance Analysis
Time frame: January 2010 - May 2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mediterranean Diet and Phase Angle, run by Federico II University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Mediterranean Diet by Predimed Questionnaire (time frame: January 2010 - May 2016). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2016.