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

ConditionsPerimenopause Aging

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Exercise + nutritional supplement
Dietary 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
Dietary 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.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Exercise + nutritional supplement (Gr 1: EXNS)Experimental treatment 1 intervention

Group B: Exercise + placebo supplement (Gr 2: EXPLA)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

Changes in Brain-Derived Neurotrophic Factor (BDNF)

Serum BDNF levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess neuroplasticity and cognition.

Time frame