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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036101
Receipt No. R000041127
Scientific Title A study for safety evaluation of 12-weeks consumption of the food containing algae
Date of disclosure of the study information 2020/03/07
Last modified on 2020/10/09

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Basic information
Public title A study for safety evaluation of 12-weeks consumption of the food containing algae
Acronym A study for safety evaluation of 12-weeks consumption of the food containing algae
Scientific Title A study for safety evaluation of 12-weeks consumption of the food containing algae
Scientific Title:Acronym A study for safety evaluation of 12-weeks consumption of the food containing algae
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is confirmation of safety of the test food when consume it continuously for 12 weeks.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) The incidence of side effects and/or adverse events.
2) The results of clinical examination.
Key secondary outcomes

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 Intake test food once a day at dinner time for 12 weeks.
Interventions/Control_2 Intake control food once a day at dinner time for 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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Healthy males and females aged 20 to 64 years old when consent acquisition.
2) Subjects who have received enough explanation about this study and were able to understand that, then giving written informed consent.
Key exclusion criteria 1) Subjects who are likely to cause allergies against test food especially algae and/or seaweeds.
2) Subjects who are given continuous treatment by taking medicines.
3) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ).
4) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
5) Subjects who excessive alcohol intake.
6) Subjects who have moderate symptom of pollen allergy.
7) Subjects who are participating the other clinical tests. Subjects who participated within three month prior to the current study and/or who plan to participate the other clinical tests.
8) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
9) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study.
10) Females who donated over 400mL blood and/or blood components within the last four month to the current study.
11) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
12) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
13) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Suguru
Middle name
Last name Fujiwara
Organization CPCC Company Limited
Division name Division of Clinical Research
Zip code 101-0047
Address 4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5297-3112
Email cpcc-contact@cpcc.co.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Ichinohe
Organization CPCC Company Limited
Division name Planning & Sales Department
Zip code 101-0047
Address 4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5297-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization KOBELCO ECO-SOLUTIONS 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 Institutional Review Board of Chiyoda Paramedical Care Clinic
Address 2F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
Tel 03-5297-5548
Email IRB@cpcc.co.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
2020 Year 03 Month 07 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 40
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 02 Month 21 Day
Date of IRB
2019 Year 02 Month 15 Day
Anticipated trial start date
2019 Year 03 Month 07 Day
Last follow-up date
2019 Year 06 Month 21 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 03 Month 06 Day
Last modified on
2020 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041127

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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