Effects of Wheat Bran Extract on Cognitive and Memory Fun... | NCT02489747

Studies
Effects of Wheat Bran Extract on Cognitive and Memory Function

NCT02489747

Sponsor

Chonbuk National University Hospital

Status

Completed

Last Update Posted

Mar 15, 2016Estimated

Enrollment

70Actual

Phase

Not Applicable

Conditions

Cognitive Function 1, Social

Interventions

WBE
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

Mar 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

Nov 2013

Primary Completion Date

Sep 2014Actual

Completion Date

Feb 2015Actual

First Submitted Date

Jun 30, 2015

First Submission Date that Met QC Criteria

Jul 1, 2015

First Posted Date

Jul 3, 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

Mar 13, 2016

Last Update Posted Date

Mar 15, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soo-Wan Chae, Professor, Chonbuk National University HospitalPrincipal Investigator

Lead Sponsor

Chonbuk National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of water extract from wheat Triticum aestivum L on cognitive and memory function. The investigators measured changes in cognitive function parameters, including CNT, WMT, K-MMSE, BCRS, PRMQ, PSS, SF-36 and BDNF

Detailed Description

Based on reports about the neuroprotective effects of water extract from wheat Triticum aestivum L. or its bran, the investigators hypothesize that extract of wheat bran (WBE) is beneficial to elderly people with age-associated cognitive impairment. The investigators investigated the efficacy and safety of WBE on improvement of cognitive function through measuring the neuropsychometric assessments in adult with subjective cognitive impairment by a randomized clinical trial.

Seventy participants aged from 50 to 80 years old with subjective cognitive impairment were randomly assigned to receive either WBE (3,000 mg/day) in this 12-week, double-blind placebo-controlled and parallel trial. Neuropsychological assessments including Computerized Neurocognitive function test (CNT), Working Memory Test (WMT), Korean Mini-Mental State Examination (K-MMSE), Brief Cognitive Rating Scale (BCRS), Prospective and Retrospective Memory Questionnaire (PRMQ), Perceived Stress Scale (PSS), 36-Item of Short-Form Health Survey (SF-36) and blood Brain-derived neurotrophic factor (BDNF) were used to assess the cognitive function before and after the intervention.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
WBE group	Experimental	wheat bran extract	Dietary Supplement: WBE
Placebo group	Placebo Comparator	placebo	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WBE	Dietary Supplement	wheat bran extract (3 g/day)	WBE group
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive function as assessed by the visual learning test score of CNT (computerized neurocognitive test)		baseline and 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Visual subset of WMT (working memory test)		baseline and 12 weeks
Cognitive function as assessed by the CNT (Computerized Neurocognitive Test) score		baseline and 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

subjects with subjective cognitive impairment
able to give informed consent

Exclusion Criteria:

history of underlying neurodegenerative disease
allergic or hypersensitive to any of the ingredients in the test products
history of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
history of alcohol or substance abuse
participation in any other clinical trials within past 2 months
laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study etc.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided