UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041019 |
|---|---|
| Receipt number | R000046843 |
| Scientific Title | A randomized and placebo-controlled double-blind, parallel-group study to investigate the cognitive efficacy of ascidian plasmalogens, |
| Date of disclosure of the study information | 2020/08/18 |
| Last modified on | 2021/12/25 16:41:44 |
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Basic information
Public title
A study of the efficacy of ascidian-derived plasmalogen supplements in maintaining visual memory
Acronym
Ascidian-derived plasmalogen supplement, a test for obtaining a functional label
Scientific Title
A randomized and placebo-controlled double-blind, parallel-group study to investigate the cognitive efficacy of ascidian plasmalogens,
Scientific Title:Acronym
A randomized and placebo-controlled double-blind, parallel-group study to investigate the cognitive efficacy of ascidian plasmalogens,
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effectiveness on cognitive function before and after ingestion of ascidian-derived plasmalogens.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CogEvo
Key secondary outcomes
Mini Mental State Examination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test Food A (2 capsules once a day)
Interventions/Control_2
Test Food B (2 capsules once a day)
Interventions/Control_3
Placebo Food (Food C)
(2 capsules once a day)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Age: 40 years old or older and under 75 years old (at the time of obtaining consent)
2.Gender: male and female
3.Inpatient and outpatient services: outpatient
4. Healthy Japanese who are experiencing memory decline
5.Those with relatively low CogEvo scores
Those who score between 22 and 27 on the Mini Mental State Examination (MMSE)
Key exclusion criteria
1.Persons taking medication for treatment of diseases (arrhythmia, liver damage, kidney damage, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension and other chronic diseases)
2.Patients with malignancy, heart failure, or myocardial infarction, or who are undergoing treatment or have a history of such treatment
3.A person suffering from dementia
4.Those suffering from mental illnesses such as depression or attention deficit/hyperactivity disorder (ADHD)
5.Persons with allergies (pharmaceuticals and test foods)
6.Those who regularly consume foods or supplements that contribute to improving cognitive function, such as DHA, EPA, Ginkgo biloba extract, tocotrienol, astaxanthin, GABA, phosphatidylserine, lutein, zeaxanthin, imidazole dipeptides (carnosine, enserine, valenine), histidine, curcumin, bacopa saponin, lactonadecapeptide, anthocyanin, seryl tyrosine, auraptene, and diosgenin.
7.Persons who regularly consume pharmaceuticals (including herbal medicines), food for specified health uses, functional foods, or other foods/beverages with possible functional properties.
8.A person who has participated in another clinical trial within one month prior to obtaining consent or who is currently participating in another clinical trial.
Those who, in the judgment of the principal investigator or sub-investigator, the conduct of the study may increase the risk to research subjects or may not provide sufficient data
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Akahori |
| Middle name | |
| Last name | Yusuke |
Organization
Yaizu Suisankagaku Industry Co., Ltd.
Division name
Research and Development Department, Development Division
Zip code
425-8570
Address
5-8-13 Kogawa-shimmachi, Yaizu City, Shizuoka Prefecture
TEL
054-621-0112
y-akahori@yskf.co.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ohno |
Organization
Clinical Creative Corporation
Division name
Pharmaceutical Development Division
Zip code
062-0933
Address
1-12-102, Hiragishi 3-13-1-12, Toyohira-ku, Sapporo City, Hokkaido
TEL
090-3116-6218
Homepage URL
k-ohno@cli-creative.com
Sponsor or person
Institute
Clinical Creative Corporation
Institute
Department
Personal name
Funding Source
Organization
Yaizu Suisan Chemical Industry Co.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Institutions Sapporo Yuurinokai Hospital Clinical Trials Committee
Address
11-186 Yurigahara, Kita-ku, Sapporo
Tel
011-771-1501
info@yurinokai.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団 札幌百合の会病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
146
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 14 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 21 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 06 | Day |
Last modified on
| 2021 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046843
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| Registered date | File name |
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