Functional exercise plus a natural supplement for perimenopausal women's health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Aquatic power training dosing strategies and creatine in older adults

  This trial tests whether different aquatic power training dosing methods and creatine supplementation help improve function in community-dwelling adults aged 60 and older.

  Recruiting University of Valencia · Valencia, Valencia · NCT07914270

• Understanding immune clues to depression in perimenopause

  This study tests whether immune and epigenetic changes during perimenopause help explain why some women develop depression.

  Recruiting at 3 sites Van Andel Research Institute · Grand Rapids, Michigan and 3 other locations · NCT07910552

• Hop extract vs soy isoflavone for menopausal symptoms

  This study tests whether a full-spectrum hop extract helps reduce menopausal mood symptoms better than soy isoflavones in peri- and postmenopausal women.

  Recruiting Menoclinica by Palacios · Madrid, Madrid · NCT07904390

• Intergenerational Interaction Program for Nursing Home Residents and Nursing Students

  A 6-week program pairs nursing home residents with nursing students to see if weekly joint activities can increase joy and reduce loneliness for older adults and lessen ageism in students.

  Recruiting Acibadem University · Istanbul · NCT07904299

• Supplemental Mobility for older adults in skilled nursing facilities

  This pilot tests whether adding a mobility aide to support walking and transfers alongside regular rehab helps older adults in SNFs after hospitalization see more daily activity and safer mobility.

  Recruiting University of Colorado, Denver · Aurora, Colorado and 1 other locations · NCT07872384

• Plant extract supplement for menopausal symptoms in women around menopause

  A plant-extract dietary supplement is being tested to see if it helps hot flashes and related symptoms in women aged 42–60 who are nearing or just past menopause, compared with a placebo.

  Recruiting University of Alicante · Elche, Alicante · NCT07863973

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.