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
Estudio de Prevención
Resumen
Fecha de inicio: 15 de diciembre de 2025
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 90 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.De 45 a 65 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
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 Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
PlaceboObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Physical activity and Sport Science Faculty, Valencia, Valencia 46010
Valencia, SpainAbrir Physical activity and Sport Science Faculty, Valencia, Valencia 46010 en Google Maps