UMIN-CTR Clinical Trial

Basic information
Public title	The effect of low temperature aged garlic extract on cognitive function
Acronym	The effect of low temperature aged garlic extract on cognitive function
Scientific Title	The effect of low temperature aged garlic extract on cognitive function
Scientific Title:Acronym	The effect of low temperature aged garlic extract on cognitive function
Region	Japan

Condition
Condition	Mild Cognitive Impairment
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of low temperature aged garlic extract containing S-allyl cysteine on cognitive function
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Cognitive function (MMSE): 12 weeks after the start of administration
Key secondary outcomes	Quality of sleep (PSQI, JESS, AIS-J) Health related QOL (SF-36) Blood, urine: 12 weeks after the start of administration

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Low temperature aged garlic extract (S-allylcysteine 250 microgram/day, 12 weeks)
Interventions/Control_2	Placebo (dextrin), 12 weeks
Interventions/Control_3
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) MMSE score before intervention is 24 to 28. (2) Those who can avoid heavy eating/drinking (3) Those who can avoid drinking the day before the test. (4) Those who and his/her proxy agree to participate in this trial in writing, after reading the explanation consent document and receiving explanations. (5) Those who have been judged by a physician to be able to understand the content of this trial and comply with the study protocol. (6) Those who are determined by the examiner to have a high probability to complete the study protocol.
Key exclusion criteria	1. Those who are receiving the medicines that affect the evaluation of this study; i.e. donepezil hydrochloride, galantamine hydrobromide, memantine hydrochloride, rivastigmine, and zonisamide. 2. Those who are taking supplement for improving cognitive function; i.e. ginkgo biloba extract, EPA / DHA, plasmalogen, phosphatidylserine / choline, anthocyanin, GABA, arachidonic acid, seryltyrosine, histidine, ferulic acid, and garden angelica. 3. Those who have history of epilepsy or brain disease. 4. Those who have been diagnosed with a malignant tumor or have a history of severe liver damage, kidney damage or heart disease. 5. Those who consume a large amount of alcohol; i.e. 60g or more of alcohol per day. 6. Those who may develop allergies to test food ingredients. 7. At screening test, the test results are classified as treatment required by the Judgment Categorydetermined by the Japan Medical Dock Association (April 1, 2018 revision, December 14, 2018 partial change). 8. Those who have been judged by a doctor to be unable to complete the study or to have a significant risk to the subject due to abnormal medical or mental conditions. 9. Those who are participting in aother clinical trial.
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Yoshio Middle name Last name Suzuki
Organization	Juntendo University
Division name	Graduate School of Health and Sports Science
Zip code	270-1695
Address	1-1, Hiragagakuenndai
TEL	+81476981001
Email	yssuzuki@juntendo.ac.jp

Public contact
Name of contact person	1st name Yoshio Middle name Sakuraba Last name Suzuki
Organization	Juntendo University
Division name	Graduate School of Health and Sports Science
Zip code	270-1695
Address	1-1, Hiragagakuenndai
TEL	+81476981001
Homepage URL
Email	yssuzuki@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	ICHIMARU PHARCOS Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics committee of Juntendo University Graduate School of Sports and Health Science
Address	1-1, Hiragagakuendai, Inzai, Chiba 270-1695
Tel	+81476981001
Email	sc-kyomu@juntendo.ac.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

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 09 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	51
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	2019 Year 07 Month 18 Day
Date of IRB	2019 Year 07 Month 18 Day
Anticipated trial start date	2019 Year 10 Month 20 Day
Last follow-up date	2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 09 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043598