UMIN-CTR Clinical Trial

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
Email	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
Email	k-ohno@cli-creative.com

Sponsor
Institute	Clinical Creative Corporation
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046843