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NCT07822230
Effects of a Dietary Intervention Based on the Dietary Guidelines for the Brazilian Population on the Reduction of Menopausal Symptoms in Overweight and Obese Women
Conditions: Menopause, Menopause Hot Flashes, Overweight , Obesity, Perimenopause, Climacteric Syndrome, Postmenopause, Menopause-related Hot Flashes, Menopause Related Conditions, Menopause Symptoms, Climactericum
Sex: Female
Ages: 40 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 74
Sponsor: Federal University of Health Science of Porto Alegre
Location: Irmandade da Santa Casa de Misericórdia de Porto Alegre Porto Alegre Rio Grande do Sul
Summary
The menopausal transition is associated with significant hormonal changes that negatively impact many women's quality of life. Vasomotor symptoms, sleep disturbances, mood changes, and genitourinary symptoms are frequently reported during this period. Concurrently, there is a tendency toward increased body weight and fat redistribution, specifically central fat accumulation, which raises the risk of metabolic diseases. Although hormonal therapy is effective, it is not suitable for all women, necessitating the consideration of non-pharmacological strategies as therapeutic alternatives. Scientific evidence indicates that healthy dietary patterns and weight loss are associated with reduced menopausal symptom severity.
The objective of the research is to evaluate the effects of a dietary intervention based on the guidelines of the Dietary Guidelines for the Brazilian Population (GAPB) on the reduction of menopausal symptoms.
A randomized clinical trial will be conducted to assess whether improving dietary quality and reducing body weight contribute to alleviating menopausal symptoms. Participants will be assigned to two groups: a control group (CG) and an intervention group (IG). Both groups will receive nutritional guidance based on the GAPB; however, the CG will receive the guidelines in printed format, whereas the IG will receive them through group sessions. The study will include perimenopausal or postmenopausal women who are overweight or obese and experiencing menopausal symptoms. Validated instruments will be administered at the beginning and end of the study to assess dietary patterns, menopausal symptoms, and nutritional status.
Eligibility Criteria
Inclusion Criteria:
* Aged 40 to 65 years
* In the perimenopausal or postmenopausal stage (based on clinical criteria and/or self-report)
* Exhibiting clinical symptoms characteristic of menopause
* Diagnosed as overweight or obese (BMI ≥ 25 kg/m²)
* Internet access via mobile phone or computer
* Agreeing to participate by signing the Informed Consent Form (ICF)
Exclusion Criteria:
* Pregnancy
* Undergoing hormone replacement therapy
* Taking medications for obesity
* Diagnosed with active neoplasms undergoing chemotherapy or immunosuppressive treatment
* Cognitive impairment
Source: ClinicalTrials.gov (NCT07822230). StuddyBuddy aggregates publicly available trial information.