Nutritional Supplement and Exercise for Perimenopausal Women's Health
The study aims to evaluate how a combination of nutritional supplements and exercise impacts brain health, stress, relaxation, mood, and inflammation in perimenopausal women.
Exercise + nutritional supplement
+ Exercise + placebo supplement
Prevention Study
Summary
Study start date: December 15, 2025
Actual date on which the first participant was enrolled.This study explores the potential benefits of a natural-origin nutritional supplement combined with a tailored physical exercise program for women going through perimenopause. Perimenopause is a transition period before menopause, marked by various symptoms such as mood swings, memory issues, and changes in fitness levels. The trial aims to understand how these combined interventions can improve mental and physical health, as well as hormone balance during this challenging phase. By focusing on non-drug strategies, the study seeks to offer safe and effective ways to enhance the well-being of perimenopausal women. Participants in the study will take part in a 10-week program, which includes a supervised exercise routine conducted three times a week, each session lasting between 45 to 60 minutes. They will also consume either the nutritional supplement or a placebo. The study will measure the impact of these interventions through various assessments, such as questionnaires on sleep, mood, and menopausal symptoms, cognitive tests, physical fitness evaluations, and blood tests checking specific biomarkers. These biomarkers include BDNF for brain health, cortisol for stress, GABA for relaxation, IL-6 for inflammation, serotonin for mood, and TNF-α for immune function. The findings will help determine how effective and safe these interventions are in improving the overall health of perimenopausal women.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 45 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Physical activity and Sport Science Faculty, Valencia, Valencia 46010
Valencia, SpainOpen Physical activity and Sport Science Faculty, Valencia, Valencia 46010 in Google Maps