UMIN-CTR Clinical Trial

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

Improvement of dietary habit

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Serum lipid concentration

Key secondary outcomes

Blood pressure determination
Pulse determination
Weight determination
Physician's history taking

Study type

Interventional

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Revitalization Promotion Program (Academic-industrial Co-creation), Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

11

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2012

Year

11

Month

22

Day

Last modified on

2015

Year

03

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011027