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Completed

NCT Number: NCT02567760

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

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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Key information

Conditions

Healthy

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MP1

Dietary Supplement

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

Placebo

Other

Subjects receive Placebo drink after meal for 8 weeks.

Primary outcomes

  1. Cognitive processing (P300) and attention (N100) using Event Related Potential

    Time frame: 7 months

Secondary outcomes

  1. Accuracy and speed of working memory using computerized battery test

    Time frame: 7 months

  2. Psychological fitness using Bond-Ladder test and Symptom Check List-90 test (SCL-90)

    Time frame: 7 months

  3. Malondialdehyde level in serum

    Time frame: 7 month

  4. The activity of Superoxide dismutase enzyme in serum

    Time frame: 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.

  5. The activity of Glutathione Peroxidase enzyme in serum

    Time frame: 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.

  6. The activity of Catalase enzyme in serum

    Time frame: 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.

  7. The activity of Acetylcholinesterase enzyme in serum

    Time frame: 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.

  8. The activity of Monoamine oxidase enzyme in serum

    Time frame: 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.

  9. Consumption safety of MP1 by using the electrocardiogram (ECG), Blood chemistry, hematology, blood pressure measurement

    Time frame: 7 months

  10. Adverse events by using adverse event record form

    Time frame: 7 months

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 5, 2015
Registry last updated
Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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