Effects of a Nutritional Supplement and Physical Exercise on the Psycho-emotional, Cognitive, Functional, and Neuroendocrine Health of Perimenopausal Women.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes in Brain-Derived Neurotrophic Factor (BDNF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Exercise + nutritional supplement (Gr 1: EXNS)
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.
干预措施: Exercise + nutritional supplement (Dietary Supplement)
Exercise + placebo supplement (Gr 2: EXPLA)
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.
干预措施: Exercise + placebo supplement (Dietary Supplement)
结局指标
主要结局
Changes in Brain-Derived Neurotrophic Factor (BDNF)
时间窗: Before and after the intervention of 10 weeks
Serum BDNF levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess neuroplasticity and cognition.
Changes in cortisol
时间窗: Before and after the intervention of 10 weeks
Serum cortisol levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess hypothalamic-pituitary-adrenal (HPA) axis-mediated physiological stress.
Changes in inteleukin 6 (IL-6)
时间窗: Before and after the intervention of 10 weeks
Serum IL-6 levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess systemic inflammation and immunity
Changes in tumor necrosis factor alfa (TNF-α)
时间窗: Before and after the intervention of 10 weeks
Serum TNF-α levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess chronic inflammation and immune state, which is related with fatigue and depression.
Changes in Gamma-aminobutyric acid (GABA)
时间窗: Before and after the intervention of 10 weeks
Serum GABA levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state to assess the state of the central nervous system, related with relaxation, anxiety and sleep conditions.
Changes in serotonin
时间窗: Before and after the intervention of 10 weeks
Serum serotonin levels will be collected through a blood sample (ELISA KIT) in the morning in a fasted state as a key neurotransmitter involved in mood regulation, sleep, and cognition.
次要结局
- Changes in state-trait anxiety(Before and after the intervention of 10 weeks)
- Change in depression(Before and after the intervention of 10 weeks)
- Changes in general well-being(Before and after the intervention of 10 weeks)
- Changes in perceived insomnia(Before and after the intervention of 10 weeks)
- Changes in daytime sleepiness(Before and after the intervention of 10 weeks)
- Changes in sleep quality(Before and after the intervention of 10 weeks)
- Changes in menopausal symptoms(Before and after the intervention of 10 weeks)
- Changes in global cognitive performance(Before and after the intervention of 10 weeks)
- Changes in working memory(Before and after the intervention of 10 weeks)
- Changes in selective attention(Before and after the intervention of 10 weeks)
- Changes in processing speed and cognitive flexibility(Before and after the intervention of 10 weeks)
- Changes in gait speed/aerobic capacity(Before and after the intervention of 10 weeks)
- Changes in lower limb strength(Before and after the intervention of 10 weeks)
- Changes in handgrip strength(Before and after the intervention of 10 weeks)
- Changes in body composition(Before and after the intervention of 10 weeks)
- Adherence to supplement and exercise(Every day for nutritional supplement and each exercise session during the 10 weeks of intervention)
研究者
Juan C. Colado
Professor of Physical Education
University of Valencia