Actively Recruiting
Effects of a Nutritional Supplement and Physical Exercise on the Psycho-emotional, Cognitive, Functional, and Neuroendocrine Health of Perimenopausal Women
Led by University of Valencia · Updated on 2025-12-22
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether a natural-origin nutritional supplement combined with a supervised functional exercise program can improve mood, sleep quality, menopausal symptoms, cognitive function, physical abilities, and neuroendocrine health in perimenopausal women. The study also aims to assess the safety of this combined intervention. This randomized, double-blind, placebo-controlled trial focuses on women aged 45 to 65 years who are in menopausal transition or postmenopause with moderate menopausal symptoms. Participants will be randomly assigned to one of two groups: one group will receive a daily natural-origin nutritional supplement along with supervised functional exercise sessions three times per week, while the other group will receive a placebo supplement combined with the same exercise program. The exercise sessions last 45 to 60 minutes and include joint mobility, postural control, functional strength using elastic bands, and coordination exercises. The intervention period lasts 10 weeks. During the study, participants will complete pre- and post-intervention assessments including questionnaires on sleep, mood, well-being, and menopausal symptoms; cognitive tests measuring attention, memory, and executive functions; physical fitness tests such as strength and gait speed; and blood tests for neuroendocrine biomarkers like cortisol, BDNF, IL-6, TNF-alpha, GABA, and serotonin. Adherence to the supplement and exercise program is monitored daily throughout the 10 weeks. The study evaluates changes in these measures to determine effects and safety of the combined intervention.
CONDITIONS
Brief Title
Impact of Funcional Exercise and Supplementation in Perimenopausal Women's Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged between 45 and 65 years
- In menopausal transition or postmenopause with irregular menstrual cycles and symptoms within the past year
- Menopause Rating Scale score of 8 or higher indicating moderate symptoms
- Regular nighttime sleep and not working shift hours
- Low physical activity less than 150 minutes per week of moderate or vigorous exercise
- Body mass index between 18.5 and 35 kg/m
- Adequate functional and cognitive ability to participate in exercise and follow the study
- Signed informed consent and ability to attend all sessions and assessments
You will not qualify if you...
- Current or recent use of hormone replacement therapy within the last 3 months
- Surgical, induced, or early menopause before age 40
- Use of medications affecting mood, sleep, or vasomotor symptoms such as antidepressants, anxiolytics, hypnotics, or hormonal supplements
- Diagnosis of severe or uncontrolled chronic diseases including cardiovascular, respiratory, metabolic, cancer, neurological, autoimmune, or psychiatric disorders
- Use of nutritional or sports supplements that may interfere with outcomes within the past 3 months
- Medical contraindications to moderate-to-vigorous exercise based on questionnaires or medical reports
- 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants take a daily nutritional supplement or placebo and attend a supervised functional exercise program with three weekly sessions, each lasting 45 to 60 minutes, for 10 weeks.
Three exercise sessions per week and daily supplement intake during the 10 weeks
Duration - Up to 1 week after treatment
Participants undergo post-intervention assessments to evaluate changes in psycho-emotional, cognitive, functional, and neuroendocrine health.
1 post-intervention visit (in-person)
Trial Site Locations
Total: 1 location
1
Physical activity and Sport Science Faculty, Valencia, Valencia 46010
Valencia, Valencia, Spain, 46010
Actively Recruiting
Research Team
J
Juan Carlos Colado Sánchez, Chair full professor
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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