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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029388
Receipt No. R000033583
Scientific Title The exploratory research on improvements in the immune system of the algae food intake A randomized, placebo-controlled, double-blind cross-over trial
Date of disclosure of the study information 2018/10/01
Last modified on 2018/10/29

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Basic information
Public title The exploratory research on improvements in the immune system of the algae food intake
A randomized, placebo-controlled, double-blind cross-over trial
Acronym The research on improvements in the immune system of the algae food intake
Scientific Title The exploratory research on improvements in the immune system of the algae food intake
A randomized, placebo-controlled, double-blind cross-over trial
Scientific Title:Acronym The research on improvements in the immune system of the algae food intake
Region
Japan

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

Objectives
Narrative objectives1 improvements in the immune system
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Immune function
Key secondary outcomes Efficacy
Objective evaluation
feeling questionnaire

Base
Study type Interventional

Study design
Basic design Cross-over
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 Treatment
Type of intervention
Food
Interventions/Control_1 algal food
Interventions/Control_2 placebo control food
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
30 years-old <=
Age-upper limit
70 years-old >
Gender Male
Key inclusion criteria (1)Healty people who are 30 or more to less than 70 years old with experiencing fatigue and stress.
(2)male.
(3)Those who tend to be in poor health condition.
(4)Individuals who are healthy and are not suffered from a chronic malady.
(5)Those who are not currently smoking cigarettes.
(6)Those from whom a written consent can be obtained on a voluntary basis.
Key exclusion criteria (1)Individuals using medical products.
(2)Individuals who are prone to allergies for foods.
(3)Individuals who intake laxatives, antiflatulent etc. aiming to improve bowel movements.
(4)Individuals who have a serious disease history or current medical history
(5)Individuals with serious anemia.
(6)Individuals who changed health food within the past 4 weeks or who started using it newly.
(7)Individuals who have been exposed to ultraviolet rays beyond their daily life within the past 4 weeks.
(8)Individuals who have irregular or disturbed life style such as night shifts.
(9)Individuals who are receiving treatment at a medical institution or those who judged to be in the relevant condition requires treatment.
(10)Individuals who have the following medical history : severe diseases (such as sugar metabolism, lipid metabolism, liver function, renal function, heart, circulatory organs, respiratory organs, endocrine system, the nervous system), or psychiatric diseases.
(11)Individuals who have history of alcohol and drug dependence.
(12)Individuals who have participated in other clinical studies within the past 1 year.
(13)Individuals judged inappropriate for the study by the principal.
Target sample size 13

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ohno Naohito
Organization Tokyo University of Pharmacy and Life Sciences
Division name Laboratory for Immunopharmacology of Microbial Products
Zip code
Address 1432-1 Horinouchi, Hachioji, Tokyo 192-0392 Japan
TEL 042-676-5561
Email ohnonao@toyaku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ootani Kazuyoshi
Organization KOBELCO ECO-SOULUTIONS CO.,LTD
Division name Algae Business Promotion Dept.
Zip code
Address 4-78, 1-chome, Wakinohama-cho, Chuo-ku, Kobe 651-0072, Japan
TEL 078-232-8223
Homepage URL
Email k.otani@kobelco-eco.co.jp

Sponsor
Institute UNITIKA GARMENTS TECNOLOGY & RESEARCH LABORATORIES. LTD.
Institute
Department

Funding Source
Organization KOBELCO ECO-SOULUTIONS 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
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

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 01 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
2017 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 02 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033583

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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