Cognitive FunctionNCT01734213
Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function
A study testing Eriobotyra Japonica Lindley Extract in people with Cognitive Function, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on improvement of Cognitive Function. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- Eriobotyra Japonica Lindley Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 May 2012to 15 Oct 2013
- 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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Males and females ≥ 65 years old
- Able to give informed consent
Who cannot join
- History of underlying neurodegenerative disease such as Alzheimer's disease, and Parkinson's disease
- Subjects with medical conditions such as Severe Dementia
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822
About this study
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on improvement of Cognitive Function. The investigators measured improvement of Cognitive Function parameters , including K-MMSE, Ability to perform working memory tasks, CNT and BCRS, and monitored their blood pressure.
- Conditions
- Cognitive Function
- Being tested
- Eriobotyra Japonica Lindley Extract, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eriobotyra Japonica Lindley ExtractDietary supplement
Eriobotyra Japonica Lindley Extract (1.5g/day)
PlaceboDietary supplement
Placebo (1.5g/day)
| Study group | Role | What they receive |
|---|---|---|
| Eriobotyra Japonica Lindley Extract | Experimental | Not described Receives: Dietary Supplement: Eriobotyra Japonica Lindley Extract |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in K-MMSE(Korean Mini-Mental State Examination)
K-MMSE(Korean Mini-Mental State Examination) was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12 weeks
Changes in ability to perform working memory tasks
Ability to perform working memory tasks was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12 weeks
Secondary outcomes (2)
Changes in CNT(Computerized neurocognitive function test)
CNT(Computerized neurocognitive function test) was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12 weeks
Changes in BCRS(Brief Cognitive Rating Scale)
BCRS(Brief Cognitive Rating Scale) was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study start10 May 2012
- Primary completion15 Oct 2013
- Study completion15 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies 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
- 60 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
- NCT01734213
- Sponsor's protocol ID
- JINR-COG-ERIO
- Status last verified
- Aug 2019
- First submitted
- 22 Nov 2012
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function
- ClinicalTrials.gov ID
- NCT01734213
- Acronym / sponsor ID
- JINR-COG-ERIO
- Conditions
- Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 10 May 2012 (actual)
- Primary completion
- 15 Oct 2013 (actual)
- Study completion
- 15 Oct 2013 (actual)
- First posted
- 27 Nov 2012 (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 Eriobotyra Japonica Lindley Extract on improvement of Cognitive Function. The investigators measured improvement of Cognitive Function parameters , including K-MMSE, Ability to perform working memory tasks, CNT and BCRS, and monitored their blood pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eriobotyra Japonica Lindley Extract | Experimental | Dietary Supplement: Eriobotyra Japonica Lindley Extract |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Males and females ≥ 65 years old
- Able to give informed consent
Key exclusion criteria (7 listed)
- History of underlying neurodegenerative disease such as Alzheimer's disease, and Parkinson's disease
- Subjects with medical conditions such as Severe Dementia
- 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
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 |
|---|---|---|
| Eriobotyra Japonica Lindley ExtractEriobotyra Japonica Lindley Extract (1.5g/day) | Dietary supplement | Eriobotyra Japonica Lindley Extract |
| PlaceboPlacebo (1.5g/day) | Dietary supplement | Placebo |
Primary outcome
Changes in K-MMSE(Korean Mini-Mental State Examination)
Time frame: 12 weeks
K-MMSE(Korean Mini-Mental State Examination) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in ability to perform working memory tasks
Time frame: 12 weeks
Ability to perform working memory tasks was measured in study visit 1(0 week) and visit 3(12 week).
2 secondary outcomes
Changes in CNT(Computerized neurocognitive function test)
Time frame: 12 weeks
Changes in BCRS(Brief Cognitive Rating Scale)
Time frame: 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 3 Sep 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eriobotyra Japonica Lindley Extract in people with Cognitive Function, run by Chonbuk National University Hospital at 1 site in South Korea.
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 7 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 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Changes in K-MMSE(Korean Mini-Mental State Examination) (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 3 Sep 2019.