Evaluation of the Relationship Between Mediterranean Diet and Menopausal Symptoms in Postmenopausal Women

December 23, 2024 updated by: Hatice Elif Ozkan Yalcinkaya, Marmara University Pendik Training and Research Hospital

Evaluation of the Relationship Between Mediterranean Diet and Menopausal Symptoms in Postmenopausal Women Aged 45-56

This cross-sectional study aimed to evaluate the relationship between the frequency and severity of postmenopausal symptoms in women aged 45-65 years and the level of compliance with the Mediterranean diet, and the main question it aimed to answer is: Do women with higher compliance with the Mediterranean diet have milder symptoms?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This cross-sectional study was conducted between 01.01.2024 and 01.06.2024 with women aged 45-65 who were registered at Tuzla E-ASM affiliated with Marmara University Pendik Hospital and who had been in menopause for at least 1 year. The sample size was calculated as 272 and the target number was determined as 305. After obtaining written consent from the participants who agreed to participate in the study and met the inclusion criteria, a questionnaire form was applied to these individuals, which questioned their sociodemographic characteristics, age of menstruation onset, pregnancy history, smoking and alcohol use, use of supplements, Mediterranean Diet Adherence Scale (MEDAS) and Menopause Rating Scale (MRS). The presence, type and severity of menopausal symptoms with the Mediterranean diet were evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
305

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Tuzla
      • İstanbul, Tuzla, Turkey, 34953
        • Marmara University- Tuzla Eğitim ASM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The population of the study consists of all postmenopausal women between the ages of 45-65 registered to Tuzla E-ASM.

Description

Inclusion Criteria:

  • Those who volunteered to participate in the study,

Exclusion Criteria:

  • Those with a diagnosed eating disorder,
  • Those using medication for obesity,
  • Those with a chronic metabolic disease that is not receiving treatment and whose values related to the disease are not regulated (pronounced hypo/hyperthyroidism, uncontrolled diabetes, etc.),
  • Those with a mental or physical condition that prevents communication (some neuropsychiatric diseases and mental retardation),
  • Those who do not understand and/or speak Turkish,
  • Those who do not give consent to participate in the study, •-Those who are currently using any hormonal supplements to prevent or reduce menopausal symptoms were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
postmenopausal women aged 45-65
Women who were registered at Tuzla E-ASM affiliated with Marmara University Pendik Hospital and who had been in menopause for at least 1 year

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mediterranean diet adherence and menopausal symptoms association
Time Frame: Data collected at a single time point upon participants' enrollment.
Mediterranean diet adherence total score and menopausal rating scale total score were inversely and weakly correlated with each other (p<0.01; r= -0.295).
Data collected at a single time point upon participants' enrollment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Menopausal symptom severity in women with low and dietary adherence
Time Frame: Data collected at a single time point upon participants' enrollment.
Women with mild menopausal symptoms had the highest adherence score with the Mediterranean diet, while women with severe symptoms had the lowest adherence score to the Mediterranean diet (p<0.01).
Data collected at a single time point upon participants' enrollment.
Vasomotor menopausal symptom severity in women with low dietary compliance
Time Frame: Data collected at a single time point upon participants' enrollment.
Mediterranean diet adherence scores were lower in the group with severe vasomotor symptoms. (p<0,05)
Data collected at a single time point upon participants' enrollment.
Psychological menopausal symptom severity in women with low dietary compliance
Time Frame: Data collected at a single time point upon participants' enrollment.
Mediterranean diet adherence scores were lower in the group with severe psychological symptoms.
Data collected at a single time point upon participants' enrollment.
Urogenital menopausal symptom severity in women with low dietary compliance
Time Frame: Data collected at a single time point upon participants' enrollment.
There is no significant relationship between urogenital symptom scores and Mediterranean diet compliance scores.
Data collected at a single time point upon participants' enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University Pendik Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Buğu Usanma Koban, Assistant Professor, Marmara University Pendik Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09.2023.1767

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participant's survey forms

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

Forms will only be shared with researchers via Drive

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings