Effects of a Nutritional Supplement and Physical Exercise on the Psycho-emotional, Cognitive, Functional, and Neuroendocrine Health of Perimenopausal Women.

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 45
Maximum Age: 65
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Spain
Physical activity and Sport Science Faculty, Valencia, Valencia 46010
RECRUITING
Valencia
Contact Information
Primary
Juan Carlos Colado Sánchez, Chair full professor
juan.colado@uv.es
(9639) 83470
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2026-07
Participants
Target number of participants: 90
Treatments
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: University of Valencia

This content was sourced from clinicaltrials.gov