Development and Evaluation of a Cognitive Enhancement Product Made From Selected Thai Herbs for Menopausal Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development and Evaluation of a Cognitive Enhancement Product Made From Selected Thai Herbs for Menopausal Women

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: MP1
* Other: Placebo


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. Exclusion Criteria: 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

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MP1 group<br>Subjects receive the MP1 product at the dose of 400 mg/day for 8 weeks. | Dietary Supplement: MP1<br>* Subjects receive MP1 drink at the dose of 400 mg/day after meal for 8 weeks.<br>|
| Placebo Comparator: Placebo group<br>Subject receive the Placebo product for 8 weeks. | Other: Placebo<br>* Subjects receive Placebo drink after meal for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive processing (P300) and attention (N100) using Event Related Potential |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Superoxide dismutase enzyme in serum | The activity of Superoxide dismutase (SOD) enzyme in serum is measured by using the biochemical assay method and the activity of SOD is expressed as units/mg protein. The higher activity of SOD enzyme is the better antioxidant effect of the intervention. | 7 month | 
| The activity of Glutathione Peroxidase enzyme in serum | The activity of Glutathione Peroxidase (GSH-Px) enzyme in serum is measured by using the biochemical assay method and the activity of GSH-Px is expressed as units/mg protein. The higher activity of GSH-Px enzyme is the better antioxidant effect of the intervention. | 7 month | 
| The activity of Catalase enzyme in serum | The activity of Catalase enzyme in serum is measured by using the biochemical assay method and the activity of CAT is expressed as units/mg protein. The higher activity of CAT enzyme is the better antioxidant effect of the intervention. | 7 month | 
| The activity of Acetylcholinesterase enzyme in serum | Acetylcholinesterase (AChE) is an enzyme that catalyzes the breakdown of Acetylcholine, a neurotransmitter for learning and memory.The activity of AChE enzyme in serum is measured by using the biochemical assay method and the result is express as mmol/min.g protein. The lower activity of AChE is the better cognitive enhancing effect of the intervention. | 7 month | 
| The activity of Monoamine oxidase enzyme in serum | Monoamine oxidase (MAO) is an enzyme that catalyzes the breakdown of Monoamine neurotransmitter , a neurotransmitter for learning and memory.The activity of MAO enzyme in serum is measured by using the biochemical assay method and the result is express as nmol/h/mg protein. The lower activity of MAO is the better cognitive enhancing effect of the intervention. | 7 month | 
| Consumption safety of MP1 by using the electrocardiogram (ECG), Blood chemistry, hematology, blood pressure measurement |  | 7 months | 
| Adverse events by using adverse event record form |  | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MP1, cognitive enhancing effect, menopausal women