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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-01-31

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.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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MP1 group

Subjects receive the MP1 product at the dose of 400 mg/day for 8 weeks.

Group Type ACTIVE_COMPARATOR

MP1

Intervention Type DIETARY_SUPPLEMENT

Subjects receive MP1 drink at the dose of 400 mg/day after meal for 8 weeks.

Placebo group

Subject receive the Placebo product for 8 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subjects receive Placebo drink after meal for 8 weeks.

Interventions

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MP1

Subjects receive MP1 drink at the dose of 400 mg/day after meal for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Subjects receive Placebo drink after meal for 8 weeks.

Intervention Type OTHER

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes