Impact of Funcional Exercise and Supplementation in Perimenopausal Women's Health
NCT ID: NCT07251296
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2025-12-15
2026-07-31
Brief Summary
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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.
Detailed Description
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The study will last a total of 10 weeks and will include a supervised functional exercise program consisting of three weekly sessions, each lasting 45 to 60 minutes. Pre- and post-intervention assessments will be conducted, including validated questionnaires on sleep quality, mood, general well-being, and menopausal symptoms; objective cognitive tests (attention, working memory, and executive functions); physical fitness assessments (strength, agility, gait speed, body composition); and blood analyses of neuroendocrine biomarkers (cortisol, BDNF, IL-6, TNF-α, GABA, and serotonin).
This methodological design will allow for both within- and between-group comparisons and the analysis of potential interactions between the interventions, in order to determine their efficacy and safety as non-pharmacological strategies to improve the overall health of perimenopausal women.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Exercise + nutritional supplement (Gr 1: EXNS)
Participants in this group will receive a 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.
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.
Exercise + placebo supplement (Gr 2: EXPLA)
Participants in this group will receive a placebo supplement identical in appearance to the active supplement, together with the same functional exercise program for 10 weeks.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
65 Years
FEMALE
No
Sponsors
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University of Valencia
OTHER
Responsible Party
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Juan C. Colado
Professor of Physical Education
Locations
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Physical activity and Sport Science Faculty, Valencia, Valencia 46010
Valencia, Valencia, Spain
Countries
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Central Contacts
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Juan Carlos Colado Sánchez, Chair full professor
Role: CONTACT
Phone: (9639) 83470
Email: [email protected]
Facility Contacts
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Juan Carlos Colado Sánchez, Chair full professor
Role: primary
Other Identifiers
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2025-FIS-4025659
Identifier Type: -
Identifier Source: org_study_id