NCT02567760

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2015

Typical duration for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

9 months

First QC Date

September 18, 2015

Last Update Submit

February 27, 2016

Conditions

Healthy

Keywords

MP1cognitive enhancing effectmenopausal women

Outcome Measures

Primary Outcomes (1)

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

    7 months

Secondary Outcomes (10)

  • 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 Superoxide dismutase enzyme in serum

    7 month

  • The activity of Glutathione Peroxidase enzyme in serum

    7 month

  • +5 more secondary outcomes

Study Arms (2)

MP1 group

ACTIVE COMPARATOR

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

Dietary Supplement: MP1

Placebo group

PLACEBO COMPARATOR

Subject receive the Placebo product for 8 weeks.

Other: Placebo

Interventions

MP1DIETARY_SUPPLEMENT

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

MP1 group
PlaceboOTHER

Subjects receive Placebo drink after meal for 8 weeks.

Placebo group

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy perimenopausal and postmenopausal women (\<5 years menstruation cessation) who live in Northeastern of Thailand.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jintanaporn Wattanathorn, PhD

    Khon Kaen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor Doctor

Study Record Dates

First Submitted

September 18, 2015

First Posted

October 5, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 1, 2016

Record last verified: 2016-02