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Nutritional Supplement and Exercise for Perimenopausal Women's Health

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Objetivo del estudio

The study aims to evaluate how a combination of nutritional supplements and exercise impacts brain health, stress, relaxation, mood, and inflammation in perimenopausal women.

Qué se está evaluando

Exercise + nutritional supplement

+ Exercise + placebo supplement

Suplemento Dietético
Quiénes están siendo reclutados

De 45 a 65 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Prevención

Controlado con Placebo
Intervencional
Inicio del estudio: diciembre de 2025
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity of Valencia
Contacto del EstudioJuan Carlos Colado Sánchez, Chair full professor
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

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.

Título OficialEffects of a Nutritional Supplement and Physical Exercise on the Psycho-emotional, Cognitive, Functional, and Neuroendocrine Health of Perimenopausal Women.
Patrocinador PrincipalUniversity of Valencia
Contacto del EstudioJuan Carlos Colado Sánchez, Chair full professor
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 90 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Prevención

Los estudios de prevención buscan evitar que se desarrolle una enfermedad. A menudo incluyen a personas en riesgo y evalúan vacunas, cambios en el estilo de vida o medicamentos preventivos.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Criterios

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.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

50% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

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.

Grupo II

Placebo
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.

Objetivos 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

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Physical activity and Sport Science Faculty, Valencia, Valencia 46010

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