UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015118 |
|---|---|
| Receipt number | 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 18:32:38 |
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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
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
shuichi.fukumoto@pokkasapporo-fb.co.jp
Sponsor or person
Institute
POKKA SAPPORO FOOD & BEVERAGE LTD
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017590
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
