Development and Evaluation of a Cognitive Enhancement Pro... | NCT02567760

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

NCT02567760

Sponsor

Khon Kaen University

Status

Completed

Last Update Posted

Mar 1, 2016Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy

Interventions

MP1
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Sep 18, 2015

First Submission Date that Met QC Criteria

Oct 2, 2015

First Posted Date

Oct 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2016

Last Update Posted Date

Mar 1, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jintanaporn Wattanathorn, Associated Professor Doctor, Khon Kaen UniversityPrincipal Investigator

Lead Sponsor

Khon Kaen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
MP1	Dietary Supplement	Subjects receive MP1 drink at the dose of 400 mg/day after meal for 8 weeks.	MP1 group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive processing (P300) and attention (N100) using Event Related Potential		7 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jintanaporn Wattanathorn, PhD	Khon Kaen University	Principal Investigator

Locations

Not provided