Unique ID issued by UMIN | UMIN000034538 |
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Receipt number | R000039175 |
Scientific Title | Safety of Daily Ingestion of the Scallop Oil: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study |
Date of disclosure of the study information | 2018/10/17 |
Last modified on | 2019/03/22 17:51:41 |
Safety of Daily Ingestion of the Scallop Oil: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Safety of the Scallop Oil
Safety of Daily Ingestion of the Scallop Oil: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Safety of the Scallop Oil
Japan |
Healthy adults
Adult |
Others
NO
To prove the safety of the scallop oil associated with 4 week daily ingestion in a randomized, double-blind, placebo-controlled, parallel group study.
Safety,Efficacy
Pragmatic
The pattern, severity and frequency of side effects related to ingestion of the test food during the ingestion period.
The pattern, severity and frequency of adverse events, BW, BFP, BMI, BP, heart rate, body temperature, hematological test (WBC, RBC, Hb, Ht, and Plt), biochemical test (AST, ALT, gamma-GTP, ALP, LDH, BUN, CRE, UA, TC, LDL-C, HDL-C, TG, phospholipid, FBG, HbA1c, TP, Alb, A/G ratio, CPK, Na, Cl, K, Ca, Mg, P, neutrophils, lymphocytes, monocytes, eosinophils, basophils), serum total fatty acid composition, erythrocyte phospholipid fatty acid composition and urine analysis (pH, protein, sugar, urobilinogen, ketone bodies and occult blood).
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
3
Prevention
Food |
Daily ingestion 3.0 g of the scallop oil for 4 weeks.
Daily ingestion 1.2 g of scallop oil and 1.8 g of the cooking oil for 4 weeks.
Daily ingestion 3.0 g of the cooking oil for 4 weeks.
20 | years-old | <= |
70 | years-old | > |
Male and Female
1. Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent.
2. Healthy subjects.
1. Subjects who regularly take anticoagulant, antiplatelet medicine, and/or NSAIDs.
2. Subjects who take ethyl icosapentate.
3. Subjects with blood coagulation disorders.
4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
5. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
7. Subjects with severe anemia.
8. Pre- or post-menopausal women complaining of obvious physical changes.
9. Subjects who are at risk of having allergic reactions to drugs or foods especially based on fish and/or gelatin.
10. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
11. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study.
12. Pregnant or lactating women or women who expect to be pregnant during this study.
13. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
14. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
39
1st name | Jun |
Middle name | |
Last name | NISHIHIRA |
Hokkaido Information University
Department of Medical Management and Informatics
069-8585
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4411
nishihira@do-johodai.ac.jp
1st name | Jun |
Middle name | |
Last name | NISHIHIRA |
Hokkaido Information University
Health Information Science Center
069-8585
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
Japan Science and Technology Agency
Japanese Governmental office
Laboratory of Food and Nutritional Sciences, Faculty of Chemistry, Materials, and Bioengineering, Kansai University
IHI Corporation
The ethics committee of Hokkaido Information University
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4411
soumu@do-johodai.ac.jp
NO
北海道情報大学 保健センター(北海道)
2018 | Year | 10 | Month | 17 | Day |
Unpublished
37
Completed
2018 | Year | 09 | Month | 25 | Day |
2018 | Year | 09 | Month | 25 | Day |
2018 | Year | 10 | Month | 16 | Day |
2018 | Year | 12 | Month | 06 | Day |
2018 | Year | 12 | Month | 21 | Day |
2019 | Year | 01 | Month | 10 | Day |
2019 | Year | 02 | Month | 28 | Day |
2018 | Year | 10 | Month | 17 | Day |
2019 | Year | 03 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039175
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