Unique ID issued by UMIN | UMIN000015141 |
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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 |
A randomized controlled trial for improving blood lipids in human
A randomized double-blind parallel-group study
A trial for improving blood lipids
A randomized controlled trial for improving blood lipids in human
A randomized double-blind parallel-group study
A trial for improving blood lipids
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To investigate the effect of "Krill oil soft capsule" on blood lipids in human.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
[Blood lipids]
total cholesterol
HDL cholesterol
LDL cholesterol
Triglyceride
free fatty acid
[Physical examination]
Weight
BMI
Body fat percentage
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
3
Treatment
Food |
Duration: 12 weeks
Test material: Krill oil
3 capsules One time / day after lunch
Duration: 12 weeks
Test material: Krill oil
3 capsules Three time / day
Duration: 12 weeks
Test material: placebo
3 capsules One time / day after lunch
30 | years-old | <= |
60 | years-old | > |
Male and Female
a) Healthy adults, who feel fatigue daily
b) Persons who are between 30 and 59 years old
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
24
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO,Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO, Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
POKKA SAPPORO FOOD & BEVERAGE LTD
Profit organization
Seishin-kai Medical Association Inc, Takara Medical Clinic.
NO
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)
2015 | Year | 06 | Month | 01 | Day |
Published
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.
Completed
2014 | Year | 07 | Month | 15 | Day |
2014 | Year | 08 | Month | 23 | Day |
2015 | Year | 01 | Month | 31 | Day |
2015 | Year | 01 | Month | 31 | Day |
2015 | Year | 01 | Month | 31 | Day |
2015 | Year | 01 | Month | 31 | Day |
2014 | Year | 09 | Month | 12 | Day |
2017 | Year | 01 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017609
Research Plan | |
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Research case data | |
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