UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040082 |
|---|---|
| Receipt number | R000045709 |
| Scientific Title | Safety verification test using a overdose of functional food 2 that intended for healthy individuals |
| Date of disclosure of the study information | 2020/07/31 |
| Last modified on | 2020/12/11 17:28:29 |
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Basic information
Public title
Safety verification test using a overdose of functional food 2 that intended for healthy individuals
Acronym
Safety verification test using a overdose of functional food 2 that intended for healthy individuals
Scientific Title
Safety verification test using a overdose of functional food 2 that intended for healthy individuals
Scientific Title:Acronym
Safety verification test using a overdose of functional food 2 that intended for healthy individuals
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will check about safety while people take test food excessively for 4 weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We confirm safety by integrating adverse events, physiological examination, hematological examination, blood biochemical examination, and urinalysis (Measuring before and 2, 4week after intake of test food.).
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
functional food
Intake:11,850 mg
Ingesion:28day
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese men and women aged more than 20 years at the time of giving informed consent.
2. A person who, during the screening period, is not using chronic or seasonal drugs or medical equipment, and is not undergoing rehabilitation therapy.
3. A person who has freely given consent and has understood the purpose of the study.
4. BMI:18.5 - 30.0
5. Excessive exercise can prevent a person from participating in the clinical study.
6. A person who can take three meals a day basically and prohibit great intemperance during the clinical study.
7. A person who can conduct contraception by an appropriate way during the clinical study.
8. Participant who understands that clinical visits are mandatory during clinical study period.
9. A person who are considered fit for the enrollment in the clinical study.
Key exclusion criteria
1. Have a disorder to absorption, distribution, metabolism, excretion of food, such as digestive tract, liver, kidney, heart and cardiovascular system
2. A person with a history of the surgery considerable in the gastrointestinal tract site, for example, gastrectomy, stomach and intestines suturation, intestinal tract resection and so on. (Excluding polypectomy and appendectomy)
3. A person with a history of cerebrovascular disorder.(Excluding asymptomatic lacunar infarct)
4. Have a medical history of food allergy disease or asthma.
5. A person with hypersensitivity or idiosyncrasy, such as food allergies.
6. Be Suspected alcohol or drug dependence
7. A parson who participated in other clinical trial at resent (past 84 days)
8. A person who has taken the blood sampling 400 mL or 200 mL within 84 days, or platelet apheresis within 14days at the time of starting this trial
11. Have a irregular habit
12. Had participated over the past 3 months, or currently participate in other clinical trials
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Okumura |
Organization
Yamada Bee Company, Inc.
Division name
Functional research section, Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
no1780@yamada-bee.com
Public contact
Name of contact person
| 1st name | Chizuru |
| Middle name | |
| Last name | Homma |
Organization
Yamada Bee Company, Inc.
Division name
Functional research section, Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
Homepage URL
ch1644@yamada-bee.com
Sponsor or person
Institute
Yamada Bee Company, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research Center for Immunological Analysis, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamada Bee Company Ethics Committee
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
Tel
0868-54-1199
th1924@yamada-bee.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 | 07 | Month | 31 | 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
12
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
| 2020 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 16 | 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 | 04 | Month | 07 | Day |
Last modified on
| 2020 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045709
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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