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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009383
Receipt No. R000011027
Scientific Title A Study for the Behavior of Ingested Test Products in Blood
Date of disclosure of the study information 2012/11/22
Last modified on 2015/03/19

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Basic information
Public title A Study for the Behavior of Ingested Test Products in Blood
Acronym A Study for the Behavior of Ingested Test Products in Blood
Scientific Title A Study for the Behavior of Ingested Test Products in Blood
Scientific Title:Acronym A Study for the Behavior of Ingested Test Products in Blood
Region
Japan

Condition
Condition Improvement of dietary habit
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine the behavior of lipid biomarkers in blood by single ingestion of three fish oil products. Test subjects are health Japanese males aged 20-30 years.
Basic objectives2 Others
Basic objectives -Others The behavior of serum lipid concentration is measured in before ingestion and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours after ingestion.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum lipid concentration
Key secondary outcomes Blood pressure determination
Pulse determination
Weight determination
Physician's history taking

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Fish oil product A 30 pills
> Washout period(6 days)
Fish oil product B30 pills
> Washout period (6 days)
Placebo products 30 pills
Interventions/Control_2 Fish oil product B30 pills
> Washout period(6 days)
Placebo product 30 pills
> Washout period (6 days)
Fish oil product A 30 pills
Interventions/Control_3 Placebo product 30 pills
> Washout period(6 days)
Fish oil product A 30 pills
> Washout period (6 days)
Fish oil product B 30 pills
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
30 years-old >
Gender Male
Key inclusion criteria *Healthy Japanese males aged 20-30 years
*Individuals whose BMI whose BMI is 18.5-25
*Individuals who are non-smoker
*Individuals who don't continually take OTC drug (including herb medicine), food with health claims (food for specified health use), health food, and supplement
*Individuals whose dietary habit is stable
*Individuals who are able to abstain from eating from 10 hours prior to blood drawing period to the end of observation
*Individuals judged appropriate for the study by the principal investigator
Key exclusion criteria *Individuals using medical products
*Individuals who are smoker
*Individuals with serious serious anemia.
*Individuals who are sensitive to medical products and cosmetics
*Individuals who have anamnesis or history of present illness of cardiovascular disease, nephritic disorder, hepatic inflammation, or pancreatitis
*Individuals whose observed data of AST, ALT and gamma-GT are over 2.5 times of standard value
*Individuals who participated in other clinical studies in the past 3 months
*Individuals judged inappropriate for the study by the principal investigator
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyotaka Nakagawa
Organization Tohoku University
Division name Division of Bioscience and Biotechnology for Future Bioindustries, Graduate School of Agricultural Science
Zip code
Address 1-1 Tsutsumidori-Amamiyamachi Aoba-ku Sendai Miyagi, 981-8555, Japan
TEL 022-717-8906
Email nkgw@biochem.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name TES Holding Co., Ltd.
Organization TES Holding Co., Ltd.
Division name Department of Clinical Trial
Zip code
Address 6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, Japan
TEL 03-6801-8480
Homepage URL
Email info@tes-h.co.jp

Sponsor
Institute Division of Bioscience and Biotechnology for Future Bioindustries, Graduate School of Agricultural Science, Tohoku University
Institute
Department

Funding Source
Organization Revitalization Promotion Program (Academic-industrial Co-creation), Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 11 Month 22 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
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
2012 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 22 Day
Last modified on
2015 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011027

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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