Clinical trial NCT06755255: Evaluation of the Relationship Between Mediterranean Diet and Menopausal Symptoms in Postmenopausal Women
Official title: Evaluation of the Relationship Between Mediterranean Diet and Menopausal Symptoms in Postmenopausal Women Aged 45-56
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopausal Complaints
Keywords: Menopausal Complaints
climacteric
menopausal symptoms
mediterranean diet
Lead sponsor: Marmara University Pendik Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 305
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mediterranean diet adherence and menopausal symptoms association
timeFrame: Data collected at a single time point upon participants' enrollment.
Secondary outcomes:
measure: Menopausal symptom severity in women with low and dietary adherence
timeFrame: Data collected at a single time point upon participants' enrollment.
measure: Vasomotor menopausal symptom severity in women with low dietary compliance
timeFrame: Data collected at a single time point upon participants' enrollment.
measure: Psychological menopausal symptom severity in women with low dietary compliance
timeFrame: Data collected at a single time point upon participants' enrollment.
measure: Urogenital menopausal symptom severity in women with low dietary compliance
timeFrame: Data collected at a single time point upon participants' enrollment.
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Marmara University- Tuzla Eğitim ASM
state: Tuzla
Study officials:
affiliation: Marmara University Pendik Training and Research Hospital
name: Buğu Usanma Koban, Assistant Professor
role: STUDY_DIRECTOR
References:
citation: Ö. Can Gürkan and M. A. Hemşirelik Yüksekokulu Kadın Sağlığı ve Hastalıkları Hemşireliği Araştırma Görevlisi, "MENOPOZ SEMPTOMLARI DEĞERLENDİRME ÖLÇEĞİNİN TÜRKÇE FORMUNUN GÜVENİRLİK VE GEÇERLİLİĞİ."
citation: 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.
citation: 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.
citation: Herber-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.
citation: Vetrani 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.
citation: L. 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.