Clinical trial NCT02567760: Development and Evaluation of a Cognitive Enhancement Product Made From Selected Thai Herbs for Menopausal Women
Official title: Development and Evaluation of a Cognitive Enhancement Product Made From Selected Thai Herbs for Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: MP1
cognitive enhancing effect
menopausal women
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive processing (P300) and attention (N100) using Event Related Potential
timeFrame: 7 months
Secondary outcomes:
measure: Accuracy and speed of working memory using computerized battery test
timeFrame: 7 months
measure: Psychological fitness using Bond-Ladder test and Symptom Check List-90 test (SCL-90)
timeFrame: 7 months
measure: Malondialdehyde level in serum
timeFrame: 7 month
measure: The activity of Superoxide dismutase enzyme in serum
timeFrame: 7 month
measure: The activity of Glutathione Peroxidase enzyme in serum
timeFrame: 7 month
measure: The activity of Catalase enzyme in serum
timeFrame: 7 month
measure: The activity of Acetylcholinesterase enzyme in serum
timeFrame: 7 month
measure: The activity of Monoamine oxidase enzyme in serum
timeFrame: 7 month
measure: Consumption safety of MP1 by using the electrocardiogram (ECG), Blood chemistry, hematology, blood pressure measurement
timeFrame: 7 months
measure: Adverse events by using adverse event record form
timeFrame: 7 months
Other outcomes:
Locations:
Study officials:
affiliation: Khon Kaen University
name: Jintanaporn Wattanathorn, PhD
role: PRINCIPAL_INVESTIGATOR
References: