UMIN-CTR Clinical Trial

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
Email	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
Email	rinsho@hc-sys.jp

Sponsor
Institute	Healthcare Systems Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048267