UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039098 |
|---|---|
| Receipt number | 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 | 2020/11/25 18:52:19 |
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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
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
s-mori-ab@morinaga.co.jp
Sponsor or person
Institute
MORINAGA & CO., LTD.
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
11
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
| 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 | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044593
