UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015141
Receipt number R000017609
Scientific Title A randomized controlled trial for improving blood lipids in human A randomized double-blind parallel-group study
Date of disclosure of the study information 2015/06/01
Last modified on 2017/01/30 18:32:58

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Basic information

Public title

A randomized controlled trial for improving blood lipids in human
A randomized double-blind parallel-group study

Acronym

A trial for improving blood lipids

Scientific Title

A randomized controlled trial for improving blood lipids in human
A randomized double-blind parallel-group study

Scientific Title:Acronym

A trial for improving blood lipids

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of "Krill oil soft capsule" on blood lipids in human.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

[Blood lipids]
total cholesterol
HDL cholesterol
LDL cholesterol
Triglyceride
free fatty acid

Key secondary outcomes

[Physical examination]
Weight
BMI
Body fat percentage


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test material: Krill oil
3 capsules One time / day after lunch

Interventions/Control_2

Duration: 12 weeks
Test material: Krill oil
3 capsules Three time / day

Interventions/Control_3

Duration: 12 weeks
Test material: placebo
3 capsules One time / day after lunch

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

30 years-old <=

Age-upper limit

60 years-old >

Gender

Male and Female

Key inclusion criteria

a) Healthy adults, who feel fatigue daily
b) Persons who are between 30 and 59 years old

Key exclusion criteria

a)Persons who have previous medical history of malignant tumor or heart failure or myocardial infarction
b)Patients being treated for at least one of following diseases atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension and other chronic disease
c)Persons who take medicines, herbal medicines
*Especially, to exclude persons who take anticoagulants, antithrombotic drug (acetylsalicylic acid, warfarin, etc.)
d)Persons who are allergic to medicines, or products related to the test material of this trial
*Especially, to exclude persons with gelatin or shellfish allergy because of including gelatin in the capsule film and shrimp essence in the placebo fragrances
e)Pregnant women, lactating women, or women who want to get pregnant during the trial period
f)Persons who plan an operation
g)Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial
h)Persons who are judged not suitable to participate in this trial by physician

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo YAMAMOTO

Organization

ORTHOMEDICO,Inc.

Division name

R&D Department

Zip code


Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.

TEL

03-3818-0610

Email

kazu@orthomedico.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoko SUZUKI

Organization

ORTHOMEDICO, Inc.

Division name

R&D Department

Zip code


Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.

TEL

03-3818-0610

Homepage URL


Email

nao@orthomedico.jp


Sponsor or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name



Funding Source

Organization

POKKA SAPPORO FOOD & BEVERAGE LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Seishin-kai Medical Association Inc, Takara Medical Clinic.

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

医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)


Other administrative information

Date of disclosure of the study information

2015 Year 06 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Fukumoto S, Katsumata Y, Yoshikawa K, Sakaida K, Suzuki N, Yamamoto K, Takara T, Yazawa K. Effect of Supplement Containing Krill Oil on Serum Lipids in Japanese-A Randomized, Double-blind, Placebo-controlled Study-. Jpn Pharmacol Ther. 2015; 43(6): 837-847.

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

2014 Year 07 Month 15 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 23 Day

Last follow-up date

2015 Year 01 Month 31 Day

Date of closure to data entry

2015 Year 01 Month 31 Day

Date trial data considered complete

2015 Year 01 Month 31 Day

Date analysis concluded

2015 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 09 Month 12 Day

Last modified on

2017 Year 01 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017609


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name