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

NCT06755255 | Completed

• 1 other identifier: 09.2023.1767
• Study Type: observational
• Target: 305
• Locations: 1 country
• Sites: 1

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?

Conditions

Menopausal Complaints

Keywords

Menopausal Complaints; climacteric; menopausal symptoms; mediterranean diet

Outcome Measures

Primary Outcomes (1)

• 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).

  Data collected at a single time point upon participants' enrollment.

Secondary Outcomes (4)

• Menopausal symptom severity in women with low and dietary adherence

  Data collected at a single time point upon participants' enrollment.

• Vasomotor menopausal symptom severity in women with low dietary compliance

  Data collected at a single time point upon participants' enrollment.

• Psychological menopausal symptom severity in women with low dietary compliance

  Data collected at a single time point upon participants' enrollment.

• Urogenital menopausal symptom severity in women with low dietary compliance

  Data collected at a single time point upon participants' enrollment.

Study Arms (1)

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

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: This study enrolls only biological females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Those who volunteered to participate in the study,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead

Study Sites (1)

Marmara University- Tuzla Eğitim ASM

Istanbul, Tuzla, 34953, Turkey (Türkiye)

Location

Related Publications (6)

• Ö. Can Gürkan and M. A. Hemşirelik Yüksekokulu Kadın Sağlığı ve Hastalıkları Hemşireliği Araştırma Görevlisi, "MENOPOZ SEMPTOMLARI DEĞERLENDİRME ÖLÇEĞİNİN TÜRKÇE FORMUNUN GÜVENİRLİK VE GEÇERLİLİĞİ."

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 39026104 BACKGROUND

• 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.

  PMID: 23553160 BACKGROUND

• 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.

  PMID: 35546996 BACKGROUND

• 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.

  BACKGROUND

Study Officials

• Buğu Usanma Koban, Assistant Professor

  Marmara University Pendik Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Family Medicine Resident

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: January 1, 2025
• Study Start: January 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months
• Access Criteria: Forms will only be shared with researchers via Drive

Locations

TU (1)