UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036101 |
|---|---|
| Receipt number | 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 11:47:03 |
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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
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
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041127
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