Impact of Funcional Exercise and Supplementation in Perimenopausal Women's Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorUniversity of Valencia
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Exercise + nutritional supplement
- Exercise + placebo supplement
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov