💬In plain words
What the trial is, and whether it could suit you
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 q
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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