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Effects of Wheat Bran Extract on Cognitive and Memory Function

C

Chonbuk National University

Status

Completed

Conditions

Cognitive Function 1, Social

Treatments

Dietary Supplement: WBE
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02489747
CTCF2_2013_WBE

Details and patient eligibility

About

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

Full 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.

Enrollment

70 patients

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups, including a placebo group

WBE group
Experimental group
Description:
wheat bran extract
Treatment:
Dietary Supplement: WBE
Placebo group
Placebo Comparator group
Description:
placebo
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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