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

NCT07251296 | Recruiting

• 1 other identifier: 2025-FIS-4025659
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Perimenopause; Aging

Keywords

Perimenopause; nutritional supplement; Functional exercise; Psycho-emotional health; Cognitive function; Non-pharmacological interevention; Randomized controlled trial; Physical function; variable resistance training; Neuroendocrine biomarkers; Sleep and mood regulation

Outcome Measures

Primary Outcomes (6)

• Changes in Brain-Derived Neurotrophic Factor (BDNF)

  Serum BDNF levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess neuroplasticity and cognition.

  Before and after the intervention of 10 weeks

• Changes in cortisol

  Serum cortisol levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess hypothalamic-pituitary-adrenal (HPA) axis-mediated physiological stress.

  Before and after the intervention of 10 weeks

• Changes in inteleukin 6 (IL-6)

  Serum IL-6 levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess systemic inflammation and immunity

  Before and after the intervention of 10 weeks

• Changes in tumor necrosis factor alfa (TNF-α)

  Serum TNF-α levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess chronic inflammation and immune state, which is related with fatigue and depression.

  Before and after the intervention of 10 weeks

• Changes in Gamma-aminobutyric acid (GABA)

  Serum GABA levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess the state of the central nervous system, related with relaxation, anxiety and sleep conditions.

  Before and after the intervention of 10 weeks

• Changes in serotonin

  Serum serotonin levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state as a key neurotransmitter involved in mood regulation, sleep, and cognition.

  Before and after the intervention of 10 weeks

Secondary Outcomes (16)

• Changes in sleep quality

  Before and after the intervention of 10 weeks

• Changes in perceived insomnia

  Before and after the intervention of 10 weeks

• Changes in daytime sleepiness

  Before and after the intervention of 10 weeks

• Changes in state-trait anxiety

  Before and after the intervention of 10 weeks

• Change in depression

  Before and after the intervention of 10 weeks

Study Arms (2)

Exercise + nutritional supplement (Gr 1: EXNS)

EXPERIMENTAL

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.

Dietary Supplement: Exercise + nutritional supplement

Exercise + placebo supplement (Gr 2: EXPLA)

PLACEBO COMPARATOR

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.

Dietary Supplement: Exercise + placebo supplement

Interventions

Exercise + nutritional supplement DIETARY_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 + nutritional supplement (Gr 1: EXNS)

Exercise + placebo supplement DIETARY_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.

Exercise + placebo supplement (Gr 2: EXPLA)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Physical activity and Sport Science Faculty, Valencia, Valencia 46010

Valencia, Valencia, 46010, Spain

RECRUITING

MeSH Terms

Interventions

Exercise; Dietary Supplements

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Juan Carlos Colado Sánchez, Chair full professor

CONTACT

(9639) 83470; juan.colado@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Education

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

ES (1)