Cognitive Function 1, SocialNCT02489747
Effects of Wheat Bran Extract on Cognitive and Memory Function
A study testing WBE in people with Cognitive Function 1, Social, run by Chonbuk National University Hospital.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function 1, Social
- What is being tested?
- WBE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects with subjective cognitive impairment
- able to give informed consent
Who cannot join
- 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.
About this study
Official title: Efficacy and Safety of Wheat Bran Extract on Improvement of 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
Read the 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.
- Conditions
- Cognitive Function 1, Social
- Being tested
- WBE, Placebo
- Keywords
- cognitive function, CNT, memory function, Triticum aestivum L, wheat bran
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WBEDietary supplement
wheat bran extract (3 g/day)
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| WBE group | Experimental | wheat bran extract Receives: Dietary Supplement: WBE |
| Placebo group | Placebo comparator | placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function as assessed by the visual learning test score of CNT (computerized neurocognitive test)
Measured: baseline and 12 weeks
Secondary outcomes (8)
Visual subset of WMT (working memory test)
Measured: baseline and 12 weeks
Cognitive function as assessed by the CNT (Computerized Neurocognitive Test) score
Measured: baseline and 12 weeks
Cognitive function as assessed by the Verbal subtest of WMT (Working Memory Test)
Measured: baseline and 12 weeks
Cognitive function as assessed by the BCRS (Brief Cognitive Rating Sclae)
Measured: baseline and 12 weeks
Memory function as assessed by the PRMQ (Prospective and Retrospective Memory Questionnaire)
Measured: baseline and 12 weeks
Stress level evaluation as assessed by the Perceived stress scale (PSS)
Measured: baseline and 12 weeks
Quality of life as assessed by the 36-item short-form healthy survey (SF-36) score
Measured: baseline and 12 weeks
Cognitive function as assessed by the Brain-Derived Neurotrophic Factor (BDNF)
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startNov 2013
- Primary completionSep 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Function 1, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489747
- Sponsor's protocol ID
- CTCF2_2013_WBE
- Status last verified
- Mar 2016
- First submitted
- 30 Jun 2015
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Wheat Bran Extract on Improvement of Cognitive and Memory Function
- ClinicalTrials.gov ID
- NCT02489747
- Acronym / sponsor ID
- CTCF2_2013_WBE
- Conditions
- Cognitive Function 1, Social
- Keywords
- cognitive function, CNT, memory function, Triticum aestivum L, wheat bran
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WBE group | Experimental | Dietary Supplement: WBEwheat bran extract |
| Placebo group | Placebo comparator | Dietary Supplement: Placeboplacebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subjects with subjective cognitive impairment
- able to give informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WBEwheat bran extract (3 g/day) | Dietary supplement | WBE group |
| PlaceboPlacebo | Dietary supplement | Placebo group |
Primary outcome
Cognitive function as assessed by the visual learning test score of CNT (computerized neurocognitive test)
Time frame: baseline and 12 weeks
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing WBE in people with Cognitive Function 1, Social, run by Chonbuk National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function as assessed by the visual learning test score of CNT (computerized neurocognitive test) (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2016.