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

Completed

Conditions

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

Observational

Enrollment (Actual)

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

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
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

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

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

Marmara University Pendik Training and Research Hospital

Investigators

  • 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)

January 1, 2024

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID 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.

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