Effects of Wheat Bran Extract on Cognitive and Memory Function

Cognitive Function 1, Social Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489747
• Other study ID #: CTCF2_2013_WBE
• Status: Completed
• Phase: N/A
• First received: June 30, 2015
• Last updated: March 13, 2016
• Start date: November 2013
• Est. completion date: February 2015

Study information

• Verified date: March 2016
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognitive Function 1, Social

Intervention

Dietary Supplement:
• WBE
wheat bran extract (3 g/day)
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Outcome

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