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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000032847
Receipt No. R000037451
Scientific Title Effects of cognicise (combined physical and cognitive exercises) and chlorella intake for prevention from dementia in elderly people.
Date of disclosure of the study information 2018/06/03
Last modified on 2020/03/10

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Basic information
Public title Effects of cognicise (combined physical and cognitive exercises) and chlorella intake for prevention from dementia in elderly people.
Acronym Effects of cognicise and chlorella intake for prevention from dementia.
Scientific Title Effects of cognicise (combined physical and cognitive exercises) and chlorella intake for prevention from dementia in elderly people.
Scientific Title:Acronym Effects of cognicise and chlorella intake for prevention from dementia.
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this trial is to investigate effects of cognicise (combined physical and cognitive exercises) and chlorella intake for prevention from dementia in elderly people.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cognitive function evaluation
Key secondary outcomes Metabolome analysis of human blood

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food Behavior,custom
Interventions/Control_1 Test group
Oral intake of tablets with 8g Chlorella extract twice a day after breakfast and supper for 6 months.
Combined physical and cognitive exercises
Interventions/Control_2 Control group
Oral intake of tablets without Chlorella extract twice a day after breakfast and supper for 6 months.
Combined physical and cognitive exercises
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
65 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Healthy Japanese men and women ages from 65 to 90 years old.
Key exclusion criteria 1)oral anticoagulants in patients
2)dementia
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kojiro
Middle name
Last name Ishii
Organization Doshisha University
Division name Faculty of Health & Sports Science
Zip code 610-0394
Address 1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL 0774-65-6724
Email kishii@mail.doshisha.ac.jp

Public contact
Name of contact person
1st name Kojiro
Middle name
Last name Ishii
Organization Doshisha University
Division name Faculty of Health & Sports Science
Zip code 610-0394
Address 1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL 0774-65-6724
Homepage URL
Email kishii@mail.doshisha.ac.jp

Sponsor
Institute Doshisha University
Institute
Department

Funding Source
Organization Sun Chlorella Corp.
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 Doshisha University Office of Ethics Review
Address Karasuma-higashi-iru, Imadegawa-dori, Kamigyo-ku, Kyoto-shi 602-8580
Tel 075-251-3158
Email ji-rinri@mail.doshisha.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
2018 Year 06 Month 03 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 14
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 Main results already published
Date of protocol fixation
2018 Year 06 Month 21 Day
Date of IRB
2018 Year 05 Month 30 Day
Anticipated trial start date
2018 Year 06 Month 21 Day
Last follow-up date
2021 Year 03 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
2018 Year 06 Month 02 Day
Last modified on
2020 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037451

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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