Aging, Perimenopause
Conditions
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
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.
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.
Interventions
DIETARY_SUPPLEMENTExercise + 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.
DIETARY_SUPPLEMENTExercise + 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.
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Brain-Derived Neurotrophic Factor (BDNF) | Before and after the intervention of 10 weeks | Serum BDNF levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess neuroplasticity and cognition. |
| Changes in cortisol | Before and after the intervention of 10 weeks | 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. |
| Changes in inteleukin 6 (IL-6) | Before and after the intervention of 10 weeks | 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 |
| Changes in tumor necrosis factor alfa (TNF-α) | Before and after the intervention of 10 weeks | 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. |
| Changes in Gamma-aminobutyric acid (GABA) | Before and after the intervention of 10 weeks | 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. |
| Changes in serotonin | Before and after the intervention of 10 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in menopausal symptoms | Before and after the intervention of 10 weeks | Menopausal symptoms will be assessed through the Menopause Rating Scale (MRS) |
| Changes in global cognitive performance | Before and after the intervention of 10 weeks | Global cognitive performance will be assessed through the Montreal Cognitive Assessment (MoCA) |
| Changes in working memory | Before and after the intervention of 10 weeks | Working memory will be assessed through the Digit Span (WAIS-IV Digit Span subtest - forward and backward) |
| Changes in selective attention | Before and after the intervention of 10 weeks | Selective attention will be assessed through the Stroop Test (short version) |
| Changes in processing speed and cognitive flexibility | Before and after the intervention of 10 weeks | Processing speed and cognitive flexibility will be assessed through the Trail Making Test A and B (TMT-A/B) |
| Changes in sleep quality | Before and after the intervention of 10 weeks | Sleep quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI) |
| Changes in lower limb strength | Before and after the intervention of 10 weeks | Lower limb strength will be assessed through the 30-s Chair Stand Test |
| Changes in handgrip strength | Before and after the intervention of 10 weeks | Handgrip strength will be assessed through the Handgrip dynamometry (Jamar Hand Dynamometer). |
| Changes in body composition | Before and after the intervention of 10 weeks | Whole body composition will be assessed through the Bioelectrical impedance analysis (Tanita BC-418). Total body mass, fat mass, fat-free mass and percentage of fat free mass will be measured. |
| Adherence to supplement and exercise | Every day for nutritional supplement and each exercise session during the 10 weeks of intervention | Adherence to supplement and exercise will be assessed through ad hoc questionnaire |
| Changes in gait speed/aerobic capacity | Before and after the intervention of 10 weeks | Gait speed/aerobic capacity will be assessed through the 6-m Walk Test |
| Changes in perceived insomnia | Before and after the intervention of 10 weeks | Perceived insomnia will be assessed through the Insomnia Severity Index (ISI) |
| Changes in daytime sleepiness | Before and after the intervention of 10 weeks | Daytime sleepiness will be assessed through the Epworth Sleepiness Scale (ESS) |
| Changes in state-trait anxiety | Before and after the intervention of 10 weeks | State-trait anxiety will be assessed through the State-Trait Anxiety Inventory (STAI-R) |
| Change in depression | Before and after the intervention of 10 weeks | Depression will be assessed through the Beck Depression Inventory-II (BDI-II) |
| Changes in general well-being | Before and after the intervention of 10 weeks | General well-being will be assessed through the WHO-5 Well-Being Index |
Countries
Spain
Contacts
Primary ContactJuan Carlos Colado Sánchez, Chair full professor
Outcome results
None listed