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NCT07251296 | RECRUITING | Perimenopause

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

University of Valencia

Information provided by (Responsible Party):

Juan C. Colado

Brief 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.

Condition or disease

Perimenopause

Aging

Intervention/treatment

Exercise + nutritional supplement

Exercise + placebo supplement

Phase

NA

Detailed Description:

This study is a randomized, double-blind, placebo-controlled clinical trial with parallel groups, designed to evaluate the effects of a natural-origin nutritional supplement combined with a functional physical exercise program on psycho-emotional, cognitive, functional, and neuroendocrine variables in perimenopausal women. Participants will be randomly assigned to the intervention groups, with both participants and outcome assessors blinded to group allocation (double-blind design). All study groups will receive a functional exercise intervention, in addition to the nutritional supplement or placebo. 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 90 participants
Masking : TRIPLE
Primary Purpose : PREVENTION
Official Title : Effects of a Nutritional Supplement and Physical Exercise on the Psycho-emotional, Cognitive, Functional, and Neuroendocrine Health of Perimenopausal Women.
Actual Study Start Date : 2025-12-15
Estimated Primary Completion Date : 2026-07
Estimated Study Completion Date : 2026-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years to 65 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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.
Exclusion Criteria
  • * Current or recent (within the last 3 months) use of hormone replacement therapy (HRT).
  • * 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.
Impact of Funcional Exercise and Supplementation in Perimenopausal Women's Health

Location Details

NCT07251296

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Spain, Valencia

Physical activity and Sport Science Faculty, Valencia, Valencia 46010

Valencia, Valencia, Spain, 46010