UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040434 |
|---|---|
| Receipt number | R000046144 |
| Scientific Title | Verification of emission effects of hazardous substances by ingestion of test foods |
| Date of disclosure of the study information | 2020/12/25 |
| Last modified on | 2020/05/18 16:36:37 |
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Basic information
Public title
Verification of emission effects of hazardous substances by ingestion of test foods
Acronym
Verification of emission effects of hazardous substances by ingestion of test foods
Scientific Title
Verification of emission effects of hazardous substances by ingestion of test foods
Scientific Title:Acronym
Verification of emission effects of hazardous substances by ingestion of test foods
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Healthy adult men and women will be given the test food continuously for 24 weeks to see how it affects the elimination of harmful substances in the body and to test its potential for detoxification.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urine test (TOX test), Mycotoxin, heavy metal test, organic acid test
Key secondary outcomes
Hematological tests, blood biochemistry tests, urinalysis, subjective quality of life questionnaires
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 consumption of the test food for 24 weeks
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women between 20 and 64 years of age
2) Applicants who have a thorough understanding of the purpose and content of the examination and who have volunteered freely and agreed to participate in the examination in writing
Key exclusion criteria
1) Those with serious diseases of the liver, kidney, heart, lung, digestive system, blood, endocrine system, and metabolic system
2) Those who have a disease requiring regular medication or a history of a serious disease requiring medication treatment
3) Those with a BMI of 26 or more
4) A person who regularly uses functional foods and supplements that may affect the discharge of hazardous substances
5) Those whose working hours are irregular due to night shift or irregular work
6) A person who smokes excessively or is a regular user of alcohol
7) Those whose lifestyle habits, such as eating and sleeping, are extremely irregular
8) Those who have donated blood within 4 weeks before obtaining consent
9) A person who has a history of hypersensitivity to test food ingredients
10) Those who are pregnant, lactating, or who intend to become pregnant during the examination period
11) Those who are participated in other clinical trials and monitored studies within one month prior to obtaining consent
12) Any other person deemed unsuitable as a subject by the study physician or study assignment physician
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Ayaka |
| Middle name | |
| Last name | Nakashima |
Organization
euglena Co., Ltd.
Division name
R&D department Functionality Research Section
Zip code
108-0014
Address
Shiba 5-29-11 Minato-ku, Toyko 108-0014, Japan
TEL
03-3453-4907
nakashima@euglena.jp
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | Nakashima |
Organization
euglena Co., Ltd.
Division name
R&D department Functionality Research Section
Zip code
108-0014
Address
Shiba 5-29-11 Minato-ku, Toyko 108-0014, Japan
TEL
03-3453-4907
Homepage URL
nakashima@euglena.jp
Sponsor or person
Institute
Square Clinic
Institute
Department
Personal name
Funding Source
Organization
euglena 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
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro, Toshima-Ku, Tokyo, Japan
Tel
03-6869-2920
nakashima@euglena.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
スクエアクリニック（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 25 | 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
5
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 09 | 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 | 05 | Month | 18 | Day |
Last modified on
| 2020 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046144
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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