UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial for improving blood lipids in human A randomized double-blind parallel-group study
Title of the study (Brief title)	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	Kazuo YAMAMOTO
Organization	ORTHOMEDICO,Inc.
Division name	R&D Department
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	Naoko SUZUKI
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017609