Actively Recruiting

Phase Not Applicable
Age: 45Years - 65Years
FEMALE
NCT07251296

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

Led by University of Valencia · Updated on 2025-12-22

90

Participants Needed

1

Research Sites

28 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged between 45 and 65 years
  • In menopausal transition or postmenopause
  • Menopause Rating Scale (MRS) score of 8 or higher
  • Regular nighttime sleep and not engaged in shift work
  • Less than 150 minutes per week of moderate or vigorous physical activity
  • Body mass index (BMI) between 18.5 and 35 kg/m²
  • Sufficient functional and cognitive capacity to participate in supervised exercise and follow protocol
  • Signed informed consent and availability to attend all sessions and assessments
Not Eligible

You will not qualify if you...

  • Current or recent (within 3 months) use of hormone replacement therapy (HRT)
  • Surgical, induced, or early menopause before age 40
  • Current treatment with medications affecting mood, sleep, or vasomotor symptoms, including antidepressants, anxiolytics, hypnotics, phytoestrogens, isoflavones, or other hormonal supplements
  • Medical diagnosis of severe or uncontrolled chronic diseases such as cardiovascular, respiratory (especially sleep apnea), metabolic, active oncological, neurological, severe autoimmune, or psychiatric disorders
  • Regular use within 3 months of nutritional or sports supplements that may interfere with outcomes
  • Medical contraindications for moderate-to-vigorous physical exercise
  • Participation in another clinical trial or intervention involving drugs, supplements, or structured exercise
  • Known allergy or intolerance to any component of the nutritional supplement

AI-Screening

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Trial Site Locations

Total: 1 location

1

Physical activity and Sport Science Faculty, Valencia, Valencia 46010

Valencia, Valencia, Spain, 46010

Actively Recruiting

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Research Team

J

Juan Carlos Colado Sánchez, Chair full professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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