UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034428 |
|---|---|
| Receipt number | R000039203 |
| Scientific Title | Preventive Effects of Chlorella on Dementia |
| Date of disclosure of the study information | 2018/10/12 |
| Last modified on | 2021/10/12 09:08:56 |
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Basic information
Public title
Preventive Effects of Chlorella on Dementia
Acronym
Preventive Effects of Chlorella on Dementia
Scientific Title
Preventive Effects of Chlorella on Dementia
Scientific Title:Acronym
Preventive Effects of Chlorella on Dementia
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Neurology | Psychiatry | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the cognitive decline prevention of Chlorella one year the for elderly people with mild cognitive impairment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
ADAS-Jcog,MMSE,MRI,SPECT,ApoA1,C3,Transthyretin
Key secondary outcomes
Serum Folate, VB12, 1alpha,25-dihydroxyvitaminD, homocysteine, Mykinso Pro
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
To intake chlorella supplements 40 tablets (8g) per day for 1 year.(20 tablets each after breakfast and dinner with 150 ml of water)
Interventions/Control_2
To intake Placebo supplements 40 tablets (8g) per day for 1 year.(20 tablets each after breakfast and dinner with 150 ml of water)
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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)People who obtained their consent after understanding the study contents on participation in this study.
2)MMSE score 25 or 26 in 50-70-year-old men and women.
Key exclusion criteria
1)People who have special diseases such as collagen disease, kidney disease, heart disease, thyroid disease (Graves' disease, Hashimoto disease), obvious infections, inflammatory bowel disease (ulcerative colitis, Crohn's disease)
2)People who will not be judged suitable to the participants by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirokawa Yoshihiro |
Organization
Hirokawa Clinic
Division name
Director
Zip code
Address
4F Mituda Building, 24-1 Ujimyouraku, Uji-shi, Kyoto
TEL
0774-22-3341
info@j-mci.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fujishima Masaki |
Organization
Sun Chlorella Corporation
Division name
Production&Development Department Research&Development Group
Zip code
Address
369 Osaka-cho, Karasuma-dori Gojo-sagaru, Shimogyo-ku, Kyoto 600-8177 Japan
TEL
075-288-3010
Homepage URL
mfujishima@sunchlorella.co.jp
Sponsor or person
Institute
Sun Chlorella Corporation
Institute
Department
Personal name
Funding Source
Organization
Sun Chlorella Corporation
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
Address
Tel
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
ひろかわクリニック
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 12 | 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
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
| 2018 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 10 | Day |
Last modified on
| 2021 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039203
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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