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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034428
Receipt No. R000039203
Scientific Title Preventive Effects of Chlorella on Dementia
Date of disclosure of the study information 2018/10/12
Last modified on 2018/12/28

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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
Email 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
Email mfujishima@sunchlorella.co.jp

Sponsor
Institute Sun Chlorella Corporation
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 13 Day
Date of IRB
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
2018 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039203

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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