Menopausal ComplaintsNCT06755255
Evaluation of the Relationship Between Mediterranean Diet and Menopausal Symptoms in Postmenopausal Women
An observational study of Menopausal Complaints, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Complaints
- How many people
- 305 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Sep 2024
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population of the study consists of all postmenopausal women between the ages of 45-65 registered to Tuzla E-ASM.
Who may be able to join
- Those who volunteered to participate in the study,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University- Tuzla Eğitim ASM
Istanbul, Tuzla, 34953
About this study
Official title: 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?
Read the 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.
- Conditions
- Menopausal Complaints
- Keywords
- Menopausal Complaints, climacteric, menopausal symptoms, mediterranean diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Mediterranean diet adherence and menopausal symptoms association
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).
Measured: Data collected at a single time point upon participants' enrollment.
Secondary outcomes (4)
Menopausal symptom severity in women with low and dietary adherence
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).
Measured: Data collected at a single time point upon participants' enrollment.
Vasomotor menopausal symptom severity in women with low dietary compliance
Mediterranean diet adherence scores were lower in the group with severe vasomotor symptoms. (p<0,05)
Measured: Data collected at a single time point upon participants' enrollment.
Psychological menopausal symptom severity in women with low dietary compliance
Mediterranean diet adherence scores were lower in the group with severe psychological symptoms.
Measured: Data collected at a single time point upon participants' enrollment.
Urogenital menopausal symptom severity in women with low dietary compliance
There is no significant relationship between urogenital symptom scores and Mediterranean diet compliance scores.
Measured: Data collected at a single time point upon participants' enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Jan 2024
- Primary completion1 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Menopausal ComplaintsStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Elif Ozkan Yalcinkaya, Marmara University Pendik Training and Research Hospital
- Investigators
- Buğu Usanma Koban, Assistant Professor, Study director, Marmara University Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755255
- Sponsor's protocol ID
- 09.2023.1767
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant's survey forms
Publications
Ö. Can Gürkan and M. A. Hemşirelik Yüksekokulu Kadın Sağlığı ve Hastalıkları Hemşireliği Araştırma Görevlisi, "MENOPOZ SEMPTOMLARI DEĞERLENDİRME ÖLÇEĞİNİN TÜRKÇE FORMUNUN GÜVENİRLİK VE GEÇERLİLİĞİ."
E. Fatma et al., "Turkish Validation and Reliability of Mediterranean Diet Adherence Screener," Pehlivanoglu Ozkan EF. Balcioglu H. Unluoglu I, vol. 42, no. 2, pp. 160-164, 2020, doi: 10.20515/otd.
Byrne-Kirk M, Mantzioris E, Scannell N, Villani A. Adherence to a Mediterranean-style diet and severity of menopausal symptoms in perimenopausal and menopausal women from Australia: a cross-sectional analysis. Eur J Nutr. 2024 Oct;63(7):2743-2751. doi: 10.1007/s00394-024-03462-3. Epub 2024 Jul 18.
PubMed 39026104Herber-Gast GC, Mishra GD. Fruit, Mediterranean-style, and high-fat and -sugar diets are associated with the risk of night sweats and hot flushes in midlife: results from a prospective cohort study. Am J Clin Nutr. 2013 May;97(5):1092-9. doi: 10.3945/ajcn.112.049965. Epub 2013 Apr 3.
PubMed 23553160Vetrani C, Barrea L, Rispoli R, Verde L, De Alteriis G, Docimo A, Auriemma RS, Colao A, Savastano S, Muscogiuri G. Mediterranean Diet: What Are the Consequences for Menopause? Front Endocrinol (Lausanne). 2022 Apr 25;13:886824. doi: 10.3389/fendo.2022.886824. eCollection 2022.
PubMed 35546996L. Barrea, G. Pugliese, D. Laudisio, S. Savastano, A. Colao, and G. Muscogiuri, "Does Mediterranean diet could have a role on age at menopause and in the management of vasomotor menopausal symptoms? The viewpoint of the endocrinological nutritionist," 2021. doi: 10.1016/j.cofs.2021.02.018.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Mediterranean Diet and Menopausal Symptoms in Postmenopausal Women Aged 45-56
- ClinicalTrials.gov ID
- NCT06755255
- Acronym / sponsor ID
- 09.2023.1767
- Conditions
- Menopausal Complaints
- Keywords
- Menopausal Complaints, climacteric, menopausal symptoms, mediterranean diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 1 Jan 2025 (actual)
- 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.
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?
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study consists of all postmenopausal women between the ages of 45-65 registered to Tuzla E-ASM.
Key inclusion criteria (1 listed)
- Those who volunteered to participate in the study,
Key exclusion criteria (6 listed)
- 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,
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
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).
4 secondary outcomes
Menopausal symptom severity in women with low and dietary adherence
Time frame: 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.
Psychological menopausal symptom severity in women with low dietary compliance
Time frame: 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.
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 1 Jan 2025.
- BackgroundÖ. Can Gürkan and M. A. Hemşirelik Yüksekokulu Kadın Sağlığı ve Hastalıkları Hemşireliği Araştırma Görevlisi, "MENOPOZ SEMPTOMLARI DEĞERLENDİRME ÖLÇEĞİNİN TÜRKÇE FORMUNUN GÜVENİRLİK VE GEÇERLİLİĞİ."
- BackgroundE. Fatma et al., "Turkish Validation and Reliability of Mediterranean Diet Adherence Screener," Pehlivanoglu Ozkan EF. Balcioglu H. Unluoglu I, vol. 42, no. 2, pp. 160-164, 2020, doi: 10.20515/otd.
- Background: PubMed 39026104Byrne-Kirk M, Mantzioris E, Scannell N, Villani A. Adherence to a Mediterranean-style diet and severity of menopausal symptoms in perimenopausal and menopausal women from Australia: a cross-sectional analysis. Eur J Nutr. 2024 Oct;63(7):2743-2751. doi: 10.1007/s00394-024-03462-3. Epub 2024 Jul 18.
- Background: PubMed 23553160Herber-Gast GC, Mishra GD. Fruit, Mediterranean-style, and high-fat and -sugar diets are associated with the risk of night sweats and hot flushes in midlife: results from a prospective cohort study. Am J Clin Nutr. 2013 May;97(5):1092-9. doi: 10.3945/ajcn.112.049965. Epub 2013 Apr 3.
- Background: PubMed 35546996Vetrani C, Barrea L, Rispoli R, Verde L, De Alteriis G, Docimo A, Auriemma RS, Colao A, Savastano S, Muscogiuri G. Mediterranean Diet: What Are the Consequences for Menopause? Front Endocrinol (Lausanne). 2022 Apr 25;13:886824. doi: 10.3389/fendo.2022.886824. eCollection 2022.
- BackgroundL. Barrea, G. Pugliese, D. Laudisio, S. Savastano, A. Colao, and G. Muscogiuri, "Does Mediterranean diet could have a role on age at menopause and in the management of vasomotor menopausal symptoms? The viewpoint of the endocrinological nutritionist," 2021. doi: 10.1016/j.cofs.2021.02.018.
- Individual participant dataSharing planned: Yes. Participant's survey forms
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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.
Buğu Usanma Koban, Assistant Professor study director
Marmara University Pendik Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopausal Complaints, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 6 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 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Mediterranean diet adherence and menopausal symptoms association (time frame: Data collected at a single time point upon participants' enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06755255, which also lists 6 linked publications.
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 1 Jan 2025.