Evaluation of Consumption Safety and Effect of Mulberry Leaves and Vietnamese Coriander Based Instant Polyherbal Porridge on Working Memory and Bone Formation Markers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Consumption Safety and Effect of Mulberry Leaves and Vietnamese Coriander Based Instant Polyherbal Porridge on Working Memory and Bone Formation Markers

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: MP 50 mg/day
* Dietary Supplement: MP 1500 mg/day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Subjects are received the placebo product which has same color and smell look like the herbal porridge containing the combined extract of mulberry and Vietnamese coriander (MP) treatments once daily for 8 weeks | Dietary Supplement: Placebo<br>* Subjects are received placebo treatments once daily for 8 weeks<br>|
| Active Comparator: MP 50 mg/day<br>Subjects are received the herbal porridge containing the combined extract of mulberry and Vietnamese coriander (MP) 50 mg/day treatments once daily for 8 weeks | Dietary Supplement: MP 50 mg/day<br>* Subjects are received MP 50 mg/day treatments once daily for 8 weeks<br>|
| Active Comparator: MP 1500 mg/day<br>Subjects are received the herbal porridge containing the combined extract of mulberry and Vietnamese coriander (MP) 1500 mg/day treatments once daily for 8 weeks | Dietary Supplement: MP 1500 mg/day<br>* Subjects are received MP 1500 mg/day treatments once daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attention (N100) and cognitive processing (P300) determine by using Event Related Potential (Auditory oddball paradigm). |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopause, Cognitive impairment, Working memory, Bone formation markers, Osteoporosis