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
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
70
Cognitive function as assessed by the visual learning test score of CNT (computerized neurocognitive test)
Time frame: baseline and 12 weeks
Visual subset of WMT (working memory test)
Time frame: baseline and 12 weeks
Cognitive function as assessed by the CNT (Computerized Neurocognitive Test) score
Time frame: baseline and 12 weeks
Cognitive function as assessed by the Verbal subtest of WMT (Working Memory Test)
Time frame: baseline and 12 weeks
Cognitive function as assessed by the BCRS (Brief Cognitive Rating Sclae)
Time frame: baseline and 12 weeks
Memory function as assessed by the PRMQ (Prospective and Retrospective Memory Questionnaire)
Time frame: baseline and 12 weeks
Stress level evaluation as assessed by the Perceived stress scale (PSS)
Time frame: baseline and 12 weeks
Quality of life as assessed by the 36-item short-form healthy survey (SF-36) score
Time frame: baseline and 12 weeks
Cognitive function as assessed by the Brain-Derived Neurotrophic Factor (BDNF)
Time frame: baseline and 12 weeks
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