Skip to main content
OpenTrials
Completed

NCT Number: NCT02489747

Effects of Wheat Bran Extract on 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cognitive Function 1, Social

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WBE

Dietary Supplement

wheat bran extract (3 g/day)

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Cognitive function as assessed by the visual learning test score of CNT (computerized neurocognitive test)

    Time frame: baseline and 12 weeks

Secondary outcomes

  1. Visual subset of WMT (working memory test)

    Time frame: baseline and 12 weeks

  2. Cognitive function as assessed by the CNT (Computerized Neurocognitive Test) score

    Time frame: baseline and 12 weeks

  3. Cognitive function as assessed by the Verbal subtest of WMT (Working Memory Test)

    Time frame: baseline and 12 weeks

  4. Cognitive function as assessed by the BCRS (Brief Cognitive Rating Sclae)

    Time frame: baseline and 12 weeks

  5. Memory function as assessed by the PRMQ (Prospective and Retrospective Memory Questionnaire)

    Time frame: baseline and 12 weeks

  6. Stress level evaluation as assessed by the Perceived stress scale (PSS)

    Time frame: baseline and 12 weeks

  7. Quality of life as assessed by the 36-item short-form healthy survey (SF-36) score

    Time frame: baseline and 12 weeks

  8. Cognitive function as assessed by the Brain-Derived Neurotrophic Factor (BDNF)

    Time frame: baseline and 12 weeks

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 3, 2015
Registry last updated
Mar 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.