NCT07251296 Impact of Funcional Exercise and Supplementation in Perimenopausal Women's Health

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 90 participants in total. It began in 2025-12-15 with a primary completion date of 2026-07.

Brief Summary

The goal of this clinical trial is to learn whether a natural-origin nutritional supplement, combined with a functional exercise program, can improve psycho-emotional, cognitive, functional, and neuroendocrine health in perimenopausal women. The study will also help determine the safety of this combined intervention. The main questions it aims to answer are: * Does the combined intervention improve mood, sleep quality, menopausal symptoms, and cognitive performance? * Does it enhance physical function and neuroendocrine regulation? Researchers will compare the supplement to a placebo. All participants will follow the same supervised functional exercise program. Participants will: * Take a daily nutritional supplement or placebo for 10 weeks * Attend three weekly supervised functional exercise sessions (45-60 minutes each) * Complete pre- and post-intervention evaluations including questionnaires, physical and cognitive tests, and blood samples for biomarker analysis.

Eligibility Criteria

Inclusion Criteria: * Women aged between 45 and 65 years. * In the menopausal transition (defined by irregular menstrual cycles and typical symptoms within the past year) or postmenopause. * Score ≥ 8 on the Menopause Rating Scale (MRS), indicating moderate menopausal symptom intensity. * Regular nighttime sleep and not engaged in shift work. * Low physical activity level: less than 150 minutes per week of moderate or vigorous physical activity, as assessed by the short-form IPAQ or a similar questionnaire. * Body mass index (BMI) between 18.5 and 35 kg/m². * Sufficient functional and cognitive capacity to participate in supervised physical exercise and follow the study protocol. * Signed informed consent and availability to attend all scheduled sessions and assessments. Exclusion Criteria: * Current or recent (within the last 3 months) use of hormone replacement therapy (HRT). * Surgical, induced, or early menopause (before age 40). * Current treatment with medications that may affect mood, sleep, or vasomotor symptoms, including: antidepressants (SSRIs, SNRIs, tricyclics); anxiolytics or hypnotics; phytoestrogens, isoflavones, or other over-the-counter hormonal supplements. * Medical diagnosis of severe or uncontrolled chronic diseases, including cardiovascular, respiratory (particularly sleep apnea), metabolic, active oncological, neurological, severe autoimmune, or psychiatric disorders. * Regular use within the past 3 months of nutritional or sports supplements that may interfere with study outcomes (e.g., creatine, protein, omega-3, adaptogens, etc.). * Medical contraindications for moderate-to-vigorous physical exercise, as determined by the PAR-Q+ questionnaire and/or updated medical report. * Simultaneous participation in another clinical trial or intervention program involving drugs, supplements, or structured physical exercise of any kind. * Known allergy or intolerance to any component of the nutritional supplement to be administered.

Contact & Investigator

Frequently Asked Questions