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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039098
Receipt No. R000044593
Scientific Title Safety Evaluation for Long-term Intake of a Test Food
Date of disclosure of the study information 2020/01/09
Last modified on 2020/07/10

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Basic information
Public title Safety Evaluation for Long-term Intake of a Test Food
Acronym Safety Evaluation for Long-term Intake of a Test Food
Scientific Title Safety Evaluation for Long-term Intake of a Test Food
Scientific Title:Acronym Safety Evaluation for Long-term Intake of a Test Food
Region
Japan

Condition
Condition N/A(healthy adults)
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate the safety of intake of a test drink for 90 days.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hematologic test, Blood biochemistry test, Urine test, Blood pressure/pulsation, Weight/body mass index, Medical Interview
0 and 90 days after a test food intake
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Oral ingestion of the test food for 90 days
Interventions/Control_2
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
64 years-old >=
Gender Male and Female
Key inclusion criteria 1) Japanese individuals aged 20-64 years.
2) Individuals who are healthy and are not suffered from a chronic malady.
3) Individuals whose written informed consent has been obtained.
4) Individuals who can visit an inspection facility and be inspected in designated days.
5) Individuals judged appropriate for the study by the principal.
Key exclusion criteria 1)Individuals using medical products.
2)Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung and blood disease.
3)Individuals who contract or have a history of serious gastrointestinal disease.
4)Individuals who have an addiction to alcohol or a mental illness.
5)Individuals who used or applied a drug for treatment of disease in the past 1 month.
6)Individuals with probable seasonal allergy, such as pollinosis, during the test period.(In particular, Betulaceae: alder, oba alnus firma, shirakaba, Taxodiaceae: cryptomeria, hinoki cypress, Asteraceae: ragweed, Artemisia vulgaris indica, Gramineae:Dactylis glomerata, Phleum pratense)
7)Individuals who have possibility of allergy symptoms onset by the test food and who cause severe allergic symptoms in foods and medicines. (In particular, gelatin, pork, apple, latex)
8)Individuals with serious anemia.
9)Individuals who are a smoker.
10)Females who are or are possibly pregnant, or are lactating.
11)Individuals whose life style will change during the test period.
12)Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
13)Individuals who were hospitalized and received treatment in the past 6 months.
14)Individuals who participated in other clinical studies in the past 1 months or will participate in other clinical studies during the test period.
15)Individuals judged inappropriate for the study by the principal.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Minoru
Middle name
Last name Morita
Organization Morinaga & Co.,Ltd
Division name Health Science and Research Center, R&D institute
Zip code 230-8504
Address 2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL 045-571-6140
Email m-morita-je@morinaga.co.jp

Public contact
Name of contact person
1st name Sadao
Middle name
Last name Mori
Organization MORINAGA & CO., LTD.
Division name Health Science and Research Center, R&D institute
Zip code 230-8504
Address 2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL 045-571-6140
Homepage URL
Email s-mori-ab@morinaga.co.jp

Sponsor
Institute MORINAGA & CO., LTD.
Institute
Department

Funding Source
Organization MORINAGA & 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 Non-Profit Organization MINS Institutional Review Board
Address 5-20-9-401,Mita,Minato-ku,Tokyo,Japan
Tel 03-6416-1868
Email npo-mins@j-irb.com

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 01 Month 09 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
2019 Year 12 Month 05 Day
Date of IRB
2019 Year 12 Month 19 Day
Anticipated trial start date
2019 Year 12 Month 26 Day
Last follow-up date
2020 Year 05 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 09 Day
Last modified on
2020 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044593

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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