Effects of Wheat Bran Extract on Cognitive and Memory Function

Efficacy and Safety of Wheat Bran Extract on Improvement of Cognitive and Memory Function

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

Study Overview

• Status: Completed
• Conditions: Cognitive Function 1, Social
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: WBE

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; placebo	Dietary supplement: Placebo; Placebo
Experimental: WBE group; wheat bran extract	Dietary supplement: WBE; wheat bran extract (3 g/day)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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
Cognitive function as assessed by the Verbal subtest of WMT (Working Memory Test)	baseline and 12 weeks
Cognitive function as assessed by the BCRS (Brief Cognitive Rating Sclae)	baseline and 12 weeks
Memory function as assessed by the PRMQ (Prospective and Retrospective Memory Questionnaire)	baseline and 12 weeks
Stress level evaluation as assessed by the Perceived stress scale (PSS)	baseline and 12 weeks
Quality of life as assessed by the 36-item short-form healthy survey (SF-36) score	baseline and 12 weeks
Cognitive function as assessed by the Brain-Derived Neurotrophic Factor (BDNF)	baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: June 30, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Estimate): March 15, 2016
• Last Update Submitted That Met QC Criteria: March 13, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: cognitive function; CNT; memory function; Triticum aestivum L; wheat bran
• Other Study ID Numbers: CTCF2_2013_WBE