Development and Evaluation of a Cognitive Enhancement Product Made From Selected Thai Herbs for Menopausal Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Cognitive processing (P300) and attention (N100) using Event Related Potential
研究概览
简要总结
This study is set up to determine the cognitive enhancing effect and consumption safety of the novel cognitive enhancement product made from the combined extract of Z. mays (purple color) and P. amaryllifolius based-drink (MP1) in menopausal volunteer.
详细描述
Memory impairment is one of the common health problems in menopausal women. Due to the therapeutic efficiency limitation, the searching for the protective intervention for this condition is required. Based on the previous findings that the combined extract of Z. mays (purple color) and P. amaryllifolius based-drink (MP1) could attenuate memory impairment in animal model of menopause, the investigators aimed to investigate the effect of MP1 functional drink on working memory, psychological fitness, possible underlying mechanism and the consumption safety in menopausal volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy perimenopausal and postmenopausal women (<5 years menstruation cessation) who live in Northeastern of Thailand.
排除标准
- •Subject who is diagnosed with one of the following: cardiovascular diseases, respiratory diseases,neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune disease and hematological disorder are excluded.
- •Hysterectomy and/or Oophorectomy
- •Subject who use hormone or any drug exerts the influence on Hypothalamic Pituitary Gonadal axis and nervous system.
- •Body mass index >27
- •Athlete or subject who has a regular exercise.
- •Smoker or heavy drinker
结局指标
主要结局
Cognitive processing (P300) and attention (N100) using Event Related Potential
时间窗: 7 months
次要结局
- Adverse events by using adverse event record form(7 months)
- The activity of Superoxide dismutase enzyme in serum(7 month)
- The activity of Glutathione Peroxidase enzyme in serum(7 month)
- Accuracy and speed of working memory using computerized battery test(7 months)
- Psychological fitness using Bond-Ladder test and Symptom Check List-90 test (SCL-90)(7 months)
- Malondialdehyde level in serum(7 month)
- The activity of Monoamine oxidase enzyme in serum(7 month)
- Consumption safety of MP1 by using the electrocardiogram (ECG), Blood chemistry, hematology, blood pressure measurement(7 months)
- The activity of Catalase enzyme in serum(7 month)
- The activity of Acetylcholinesterase enzyme in serum(7 month)
研究者
Jintanaporn Wattanathorn
Associated Professor Doctor
Khon Kaen University