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
Étude de prévention
Résumé
Date de début de l'étude : 15 décembre 2025
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.90 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.De 45 à 65 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
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.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
50% de chances d'être dans le groupe placebo en aveugle
Groupes de traitement
Groupe I
ExpérimentalGroupe II
PlaceboObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Physical activity and Sport Science Faculty, Valencia, Valencia 46010
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