Healthy
Conditions
Keywords
MP1, cognitive enhancing effect, menopausal women
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTMP1
Subjects receive MP1 drink at the dose of 400 mg/day after meal for 8 weeks.
OTHERPlacebo
Subjects receive Placebo drink after meal for 8 weeks.
Sponsors
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive processing (P300) and attention (N100) using Event Related Potential | 7 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 7 month | 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. |
| The activity of Glutathione Peroxidase enzyme in serum | 7 month | 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. |
| Accuracy and speed of working memory using computerized battery test | 7 months | — |
| The activity of Acetylcholinesterase enzyme in serum | 7 month | 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. |
| The activity of Monoamine oxidase enzyme in serum | 7 month | 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. |
| 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 | — |
| The activity of Catalase enzyme in serum | 7 month | 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. |
Outcome results
None listed