UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044188
Receipt number R000050425
Scientific Title Effect of single intake of two different types of fish oil supplements on pharmacokinetics. -A randomized, double-blinded, crossover study-
Date of disclosure of the study information 2021/05/12
Last modified on 2021/11/29 10:44:48

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Basic information

Public title

Effect of single intake of two different types of fish oil supplements on pharmacokinetics. -A randomized, double-blinded, crossover study-

Acronym

Effect of single intake of two different types of fish oil supplements on pharmacokinetics.

Scientific Title

Effect of single intake of two different types of fish oil supplements on pharmacokinetics. -A randomized, double-blinded, crossover study-

Scientific Title:Acronym

Effect of single intake of two different types of fish oil supplements on pharmacokinetics.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of single intake of two different types of fish oil supplements on pharmacokinetics.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Area under the blood concentration-time curve of delta-DHA.

Key secondary outcomes

Area under the blood concentration-time curve of DHA.
Area under the blood concentration-time curve of EPA, delta-EPA.
Blood concentration of DHA and EPA at each time point after ingestion of the test food.
Cmax,Tmax of DHA or EPA.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake of test food (single ingestion) - washout period - intake of control food (single ingestion).

Interventions/Control_2

Intake of control food (single ingestion) - washout period - intake of test food (single ingestion).

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. Age: 20 -65 years old
2. Sex : Male or Female
3. BMI:18.5 -25.0 kg/m2

Key exclusion criteria

1. Patient with dyslipidaemia.
2. Subjects with severe liver diseases, digestive organ diseases, kidney diseases and heart diseases.
3. Subjects who have history of surgical resection of the gastrointestinal tract (except for appendectomy).
4. Subjects who have various symptoms of indigestion (diarrhea, stomach feels upset etc.).
5. Subjects who are bleeding at present or danger of bleeding (serious injuries and operations, etc.)
6. Can't stop to take a supplement or medicine including DHA, EPA during the study period.
7. Difficulty in collecting blood.
8. Smoker
9. Subjects who are planned to participate in other clinical study.
10. Subjects who intend to become pregnant or lactating.
11. Subjects who are judged as unsuitable for the study by the investigator for other reason.

Target sample size

16


Research contact person

Name of lead principal investigator

1st name Kei
Middle name
Last name Yui

Organization

FANCL Corporation

Division name

Research Institute, Health science research center

Zip code

244-0806

Address

12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan

TEL

045-820-3755

Email

ke-yui@fancl.co.jp


Public contact

Name of contact person

1st name Mariko
Middle name
Last name Hayashida

Organization

FANCL Corporation

Division name

Research Institute, Health science research center

Zip code

244-0806

Address

12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan

TEL

045-820-3667

Homepage URL


Email

mariko1512@fancl.co.jp


Sponsor or person

Institute

FANCL Corporation

Institute

Department

Personal name



Funding Source

Organization

FANCL Corporation

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

Clinical Research Ethics Committee of FANCL Corporation

Address

12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan

Tel

045-820-3657

Email

akihide_nisihara@fancl.co.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

株式会社ファンケル 総合研究所(神奈川県)


Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 12 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

2021 Year 04 Month 30 Day

Date of IRB

2021 Year 05 Month 11 Day

Anticipated trial start date

2021 Year 05 Month 12 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 05 Month 12 Day

Last modified on

2021 Year 11 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050425


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name