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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038247
Receipt No. R000043598
Scientific Title The effect of low temperature aged garlic extract on cognitive function
Date of disclosure of the study information 2019/10/09
Last modified on 2020/10/09

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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/ctr_e/ctr_view.cgi?recptno=R000043598

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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