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

NCT07251296 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-12-22

No results posted yet for this study

Summary

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

  • Perimenopause
  • Aging

Interventions

DIETARY_SUPPLEMENT

Exercise + nutritional 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.

DIETARY_SUPPLEMENT

Exercise + placebo 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.

Sponsors & Collaborators

  • University of Valencia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07251296 on ClinicalTrials.gov