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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: Placebo; Dietary Supplement: MP1

• Registration Number: NCT02567760
• Lead Sponsor: Khon Kaen University

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-05
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-27
• Last Update Posted: 2016-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Subject receive the Placebo product for 8 weeks.
MP1 group	MP1	Subjects receive the MP1 product at the dose of 400 mg/day for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Cognitive processing (P300) and attention (N100) using Event Related Potential	7 months

Secondary Outcome Measures

Name	Time	Method
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
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 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
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.
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.
Adverse events by using adverse event record form	7 months