Clinical trial NCT02489747: Effects of Wheat Bran Extract on Cognitive and Memory Function
Official title: Efficacy and Safety of Wheat Bran Extract on Improvement of Cognitive and Memory Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function 1, Social
Keywords: cognitive function
CNT
memory function
Triticum aestivum L
wheat bran
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Cognitive function as assessed by the visual learning test score of CNT (computerized neurocognitive test)
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Visual subset of WMT (working memory test)
timeFrame: baseline and 12 weeks
measure: Cognitive function as assessed by the CNT (Computerized Neurocognitive Test) score
timeFrame: baseline and 12 weeks
measure: Cognitive function as assessed by the Verbal subtest of WMT (Working Memory Test)
timeFrame: baseline and 12 weeks
measure: Cognitive function as assessed by the BCRS (Brief Cognitive Rating Sclae)
timeFrame: baseline and 12 weeks
measure: Memory function as assessed by the PRMQ (Prospective and Retrospective Memory Questionnaire)
timeFrame: baseline and 12 weeks
measure: Stress level evaluation as assessed by the Perceived stress scale (PSS)
timeFrame: baseline and 12 weeks
measure: Quality of life as assessed by the 36-item short-form healthy survey (SF-36) score
timeFrame: baseline and 12 weeks
measure: Cognitive function as assessed by the Brain-Derived Neurotrophic Factor (BDNF)
timeFrame: baseline and 12 weeks
Other outcomes:
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