Exercise + nutritional supplement: Participants in this group will receive an oral daily dose of the natural-origin nutritional supplement in combination with a supervised functional exercise program (3 sessions per week, 45-60 minutes each) for 10 weeks, composed by three exercise blocks: 1) joint mobility and postural control exercises block, 2) functional strength block with three sets of two explosive strength exercises using elastic bands at 70% of 1RM and, 3) coordination and agility exercises block.
Exercise + placebo supplement: Participants in this group will receive an oral placebo supplement identical in appearance to the active supplement, together with the same functional exercise program for 10 weeks.
Study 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
Sex
FEMALE
Min age
45 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Changes in Brain-Derived Neurotrophic Factor (BDNF) — Before and after the intervention of 10 weeks Serum BDNF levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess neuroplasticity and cognition.
Changes in cortisol — Before and after the intervention of 10 weeks Serum cortisol levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess hypothalamic-pituitary-adrenal (HPA) axis-mediated physiological stress.
Changes in inteleukin 6 (IL-6) — Before and after the intervention of 10 weeks Serum IL-6 levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess systemic inflammation and immunity
Changes in tumor necrosis factor alfa (TNF-α) — Before and after the intervention of 10 weeks Serum TNF-α levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess chronic inflammation and immune state, which is related with fatigue and depression.
Changes in Gamma-aminobutyric acid (GABA) — Before and after the intervention of 10 weeks Serum GABA levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess the state of the central nervous system, related with relaxation, anxiety and sleep conditions.
Changes in serotonin — Before and after the intervention of 10 weeks Serum serotonin levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state as a key neurotransmitter involved in mood regulation, sleep, and cognition.
Trial sites (1)
Facility
City
Region
Status
Physical activity and Sport Science Faculty, Valencia, Valencia 46010
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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