UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042277 |
|---|---|
| Receipt number | R000048267 |
| Scientific Title | Verification of changes in physical condition of citizen runners and blood EPA/AA ratio due to ingestion of gummy candy containing EPA & DHA |
| Date of disclosure of the study information | 2020/10/29 |
| Last modified on | 2021/05/10 10:54:37 |
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Basic information
Public title
Verification of changes in physical condition of citizen runners and blood EPA/AA ratio due to ingestion of gummy candy containing EPA & DHA
Acronym
Verification of changes in physical condition of citizen runners and blood EPA/AA ratio due to ingestion of gummy candy containing EPA & DHA
Scientific Title
Verification of changes in physical condition of citizen runners and blood EPA/AA ratio due to ingestion of gummy candy containing EPA & DHA
Scientific Title:Acronym
Verification of changes in physical condition of citizen runners and blood EPA/AA ratio due to ingestion of gummy candy containing EPA & DHA
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the effect of ingesting EPA & DHA-containing gummies on physical condition and the blood EPA / AA ratio.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical condition evaluation by questionnaire (1 month and 2 months after ingestion)
Key secondary outcomes
EPA test (blood EPA / AA ratio), runner self-recording at recording sessions, mileage, preference survey of test food (1 month and 2 months after ingestion)
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
Ingest 5 tablets of EPA & DHA gummies daily (EPA/DHA 860 mg) for 2 months (60 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Citizen runners aged 20 and over at the time of consent
Key exclusion criteria
1. Persons who are taking drugs such as anticoagulants (e.g., warfarin, edoxaban) during treatment for a specific disease and have decreased hemostatic function
2. Persons who have been diagnosed with a bleeding disorder and have decreased hemostatic function
3. Persons who have experienced shock symptoms, allergic symptoms, or anemia when collecting or injecting blood at a medical institution, etc.
4. Persons who have experienced anemia during normal bleeding
5. Persons e who usually get red and swollen just by being bitten by a mosquito and do not heal easily
6. Persons who are currently significantly ill and have weakened immunity
7. Persons who are allergic to blue fish and gelatin
8. Persons who regularly use medicines, health foods, and supplements that may affect EPA / AA levels
9. Persons who participated or planning to participate in other clinical trials / monitor studies (excluding observational studies) within one month before obtaining consent to participate in this study, or after obtaining consent to participate in this study.
10. Persons who are judged by the principal investigator to be inappropriate for participation in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hirohito |
| Middle name | |
| Last name | Ishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
1050004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
rinsho@hc-sys.jp
Public contact
Name of contact person
| 1st name | Hirohito |
| Middle name | |
| Last name | Ishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
1050004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
Homepage URL
rinsho@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon Suisan Kaisha, 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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 | 10 | Month | 29 | 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
29
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 | 10 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | 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 | 10 | Month | 29 | Day |
Last modified on
| 2021 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048267
