Effects of Wheat Bran Extract on Cognitive and Memory Function

NCT ID: NCT02489747

Last Updated: 2016-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-02-28

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.

Conditions

Cognitive Function 1, Social

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

WBE group

wheat bran extract

Group Type: EXPERIMENTAL

WBE

Intervention Type: DIETARY_SUPPLEMENT

wheat bran extract (3 g/day)

Placebo group

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Interventions

WBE

wheat bran extract (3 g/day)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chonbuk National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soo-Wan Chae

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CTCF2_2013_WBE

Identifier Type: -

Identifier Source: org_study_id