Functional exercise plus a natural supplement for perimenopausal women's health
Effects of a Nutritional Supplement and Physical Exercise on the Psycho-emotional, Cognitive, Functional, and Neuroendocrine Health of Perimenopausal Women.
This trial will test whether a natural nutritional supplement combined with supervised functional exercise can help improve mood, sleep, menopausal symptoms, thinking, and physical function in perimenopausal women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | Female |
| Sponsor | University of Valencia Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT07251296 on ClinicalTrials.gov |
What this trial studies
This is a 10-week randomized, double-blind, placebo-controlled trial that compares a natural-origin nutritional supplement to a placebo while all participants follow the same supervised functional exercise program three times per week. Participants undergo pre- and post-intervention questionnaires, objective cognitive tests, physical fitness assessments, and blood sampling for neuroendocrine and inflammatory biomarkers. The design allows within- and between-group comparisons to determine the effects and safety of the combined intervention. Outcomes include mood, sleep quality, menopausal symptom scores, cognitive performance, physical function, and biomarkers such as cortisol, BDNF, IL-6, TNF-α, GABA, and serotonin.
Who should consider this trial
Good fit: Women aged 45–65 in the menopausal transition or postmenopause with moderate menopausal symptoms, low physical activity (<150 min/week), BMI 18.5–35 kg/m², and the capacity to participate in supervised exercise are ideal candidates.
Not a fit: Patients currently on recent hormone replacement therapy, those with early or surgical menopause, or those unable to safely participate in supervised exercise are unlikely to meet eligibility or receive benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined intervention could offer a non-drug option to reduce menopausal symptoms, improve mood and sleep, boost cognitive and physical function, and favorably modulate stress and inflammatory biomarkers.
How similar studies have performed: Exercise programs and some nutritional supplements have shown modest benefits for mood, sleep, and function in menopause, but combined supplement-plus-exercise randomized, placebo-controlled trials are less common and results have been mixed.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Valencia, Valencia
- Physical activity and Sport Science Faculty, Valencia, Valencia 46010 — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Juan Carlos Colado Sánchez, Chair full professor
- Email: juan.colado@uv.es
- Phone: (9639) 83470
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.