Impact of Funcional Exercise and Supplementation in Perimenopausal Women's Health

Официальное название

Effects of a Nutritional Supplement and Physical Exercise on the Psycho-emotional, Cognitive, Functional, and Neuroendocrine Health of Perimenopausal Women.

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Exercise + 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.
• Пищевая добавка Exercise + 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.

Первичные конечные точки

• Changes in Brain-Derived Neurotrophic Factor (BDNF) [Срок оценки: Before and after the intervention of 10 weeks]
• Changes in cortisol [Срок оценки: Before and after the intervention of 10 weeks]
• Changes in inteleukin 6 (IL-6) [Срок оценки: Before and after the intervention of 10 weeks]
• Changes in tumor necrosis factor alfa (TNF-α) [Срок оценки: Before and after the intervention of 10 weeks]
• Changes in Gamma-aminobutyric acid (GABA) [Срок оценки: Before and after the intervention of 10 weeks]
• Changes in serotonin [Срок оценки: Before and after the intervention of 10 weeks]

Вторичные конечные точки (12)

• Changes in sleep quality [Срок оценки: Before and after the intervention of 10 weeks]
• Changes in perceived insomnia [Срок оценки: Before and after the intervention of 10 weeks]
• Changes in daytime sleepiness [Срок оценки: Before and after the intervention of 10 weeks]
• Changes in state-trait anxiety [Срок оценки: Before and after the intervention of 10 weeks]
• Change in depression [Срок оценки: Before and after the intervention of 10 weeks]
• Changes in general well-being [Срок оценки: Before and after the intervention of 10 weeks]
• Changes in menopausal symptoms [Срок оценки: Before and after the intervention of 10 weeks]
• Changes in global cognitive performance [Срок оценки: Before and after the intervention of 10 weeks]
• Changes in working memory [Срок оценки: Before and after the intervention of 10 weeks]
• Changes in selective attention [Срок оценки: Before and after the intervention of 10 weeks]
• Changes in processing speed and cognitive flexibility [Срок оценки: Before and after the intervention of 10 weeks]
• Changes in gait speed/aerobic capacity [Срок оценки: Before and after the intervention of 10 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Physical activity and Sport Science Faculty, Valencia, Valencia 46010 — Valencia

Идентификаторы

NCT: NCT07251296 · 2025-FIS-4025659

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗