UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015118
Receipt No. R000017590
Scientific Title An open trial for improving lipid metabolism in human An open trial
Date of disclosure of the study information 2015/06/01
Last modified on 2017/01/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title An open trial for improving lipid metabolism in human
An open trial
Acronym A trial for improving lipid metabolism
Scientific Title An open trial for improving lipid metabolism in human
An open trial
Scientific Title:Acronym A trial for improving lipid metabolism
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of "Krill oil" on the health index.
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
Key secondary outcomes [Liver function test]
AST (GOT)
ALT (GPT)
gamma-GTP
[Gout test]
Uric acid
[Diabetes mellitus test]
Blood glucose level
Hemoglobin A1c
[Anemia test]
White blood cell count
Red blood cell count
Hemoglobin level
Hematocrit
[Physical examination]
Body height
Weight
Blood pressure
Waist circumference
Diet survey
[Urine test]
Urine protein
Sugar in urine
Occult blood in urine

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration : 8 week
Test material: Krill oil (soft capsule)

3 capsules One time (Time to ingestion is free.)
Interventions/Control_2
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
25 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria a) Persons who are between 25 and 64 years old
Key exclusion criteria a)Persons who are allergic to crustacea such as shrimp or crab, or gelatin
b)Persons who take anticoagulants, antithrombotic drug (aspirin, warfarin, etc.)
c)Persons who plan an operation before and after the study period (September to December)
d)Persons who take hyperlipidemia drug, hypercholesterolemia drug
*Persons who take drug including EPA or DHA
e)Pregnant women, lactating women, or women who want to get pregnant during the trial period
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko YOSHIKAWA
Organization POKKA SAPPORO FOOD & BEVERAGE LTD
Division name Corporate Planning Division New Category Development Group
Zip code
Address YEBISU GARDEN PLACE, 4-20-1 Yebisu, Shibuya-ku, Tokyo
TEL 03-5795-1201
Email kazuhiko.yoshikawa@pokkasapporo-fb.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuuichi FUKUMOTO
Organization POKKA SAPPORO FOOD & BEVERAGE LTD
Division name Corporate Planning Division New Category Development Group
Zip code
Address YEBISU GARDEN PLACE, 4-20-1 Yebisu, Shibuya-ku, Tokyo
TEL 03-5795-1201
Homepage URL
Email shuichi.fukumoto@pokkasapporo-fb.co.jp

Sponsor
Institute POKKA SAPPORO FOOD & BEVERAGE LTD
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 ポッカサッポロフード&ビバレッジ株式会社 恵比寿本社
POKKA SAPPORO FOOD & BEVERAGE LTD the head office in Yebisu

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, Ito Y, Morimoto Y, Kawase A, Sakaida K, Suzuki N, Yamamoto K, Takara T, Yazawa K. Effect of Krill Oil Intake on Human Serum Lipids-An Open Clinical Trial-. Jpn Pharmacol Ther. 2015; 43(5): 679-685.
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 18 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 12 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 11 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=R000017590

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.