UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038247 |
|---|---|
| Receipt number | 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 11:18:24 |
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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
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
yssuzuki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043598
