Evaluation of Consumption Safety and Effect of Mulberry Leaves and Vietnamese Coriander Based Instant Polyherbal Porridge on Working Memory and Bone Formation Markers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Attention (N100) and cognitive processing (P300) determine by using Event Related Potential (Auditory oddball paradigm).
研究概览
简要总结
This study the investigators aimed to determine the effect of the herbal porridge containing the combined extract of mulberry and Vietnamese coriander (MP) on cognitive function and bone formation markers of menopausal women. Forty-five participants were randomly assigned to receive a placebo or MP (50, 1500 mg) treatments once daily for 8 weeks.
详细描述
At present, the novel cheap and effective intervention against menopause related symptoms such as memory impairment and osteoporosis is still required due to the increased breast cancer risk induced by hormone replacement therapy. Based on the role of oxidative stress on cognitive deficit in menopause and the synergistic effect of herbs in traditional folklore, the cognitive enhancing effects and anti-osteoporosis effects of the functional food containing the combined extract of herbs possessing antioxidant effect has gained attention. Therefore, we aimed to determine the effect of the herbal porridge containing the combined extract of mulberry and Vietnamese coriander (MP) on cognitive function and bone formation markers of menopausal women. Forty-five participants were randomly assigned to receive a placebo or MP (50, 1500 mg) treatments once daily for 8 weeks. The cognitive function and working memory were assessed via the auditory oddball paradigm of event-related potentials and computerized battery tests respectively prior to the intervention, 1 month, 2 month, and at delay 1 month. Bone formation markers including serum calcium, alkaline phosphatase, and osteocalcin were determine prior to the intervention and at the end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
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.
- •Aged between 45-60 years old
- •All volunteers don't have serious physical illness such as diabetes, high blood pressure, heart disease, liver disease, kidney disease, lung disease, allergies and mental disorder.
- •All volunteers don't get medicine or hormone or other medicines that affect the nervous system and bone during the trial and within three months before the start of the test.
- •All volunteers don't smoking more than 10 pieces/ day
- •All volunteers don't have alcohol addiction
- •On the day of the study, all volunteers felt well and refrain from drinking tea, coffee or alcohol at least 12 hour.
排除标准
- •Volunteers who have been diagnosed with one of the following; cardiovascular diseases, respiratory diseases, neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune disease, hematological disorder, and gout or high uric acid.
- •Volunteers who exposed to pesticides during one week before the test.
- •Volunteers who have been Hysterectomy and/or Oophorectomy
- •Volunteers who use hormone or any drug that effect on Hypothalamic Pituitary Gonadal axis and nervous system.
- •Volunteers who require supplements or any drug that effect on the nervous system by order of the doctor during trial.
- •Alcohol addiction
- •Smoking addiction (smoking more than 10 pieces/ day)
- •Athlete or volunteers who have a regular exercise more than 3 time/weeks
- •Volunteers who don't follow instructions during the trial.
- •Volunteers who participate in other projects.
结局指标
主要结局
Attention (N100) and cognitive processing (P300) determine by using Event Related Potential (Auditory oddball paradigm).
时间窗: 3 months
次要结局
- Accuracy and time response of working memory by using computerized batteries test (CDR)(3 months)
- Bone formation marker by using serum calcium, serum alkaline phosphatase and serum osteocalcin(2 months)
- Acetylcholinesterase and monoamine oxidase type A ,B activities in serum(2 months)
- Psychological symptom by using SCL-90 questionnaire(3 months)
- Consumption safety of MP product by using the electrocardiogram (ECG), hematology, blood chemistry and blood pressure measurement.(3 months)
研究者
Jintanaporn Wattanathorn
Associate Professor Doctor
Khon Kaen University