Unique ID issued by UMIN | UMIN000034627 |
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Receipt number | R000039455 |
Scientific Title | Effect of Daily Intake of Salmon Milt DNA-Na on Liver Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study (Confirmatory Trial) |
Date of disclosure of the study information | 2018/10/25 |
Last modified on | 2019/11/21 08:48:49 |
Effect of Daily Intake of Salmon Milt DNA-Na on Liver Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study (Confirmatory Trial)
Beneficial Effects of Salmon Milt DNA-Na on Liver Function
Effect of Daily Intake of Salmon Milt DNA-Na on Liver Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study (Confirmatory Trial)
Beneficial Effects of Salmon Milt DNA-Na on Liver Function
Japan |
Healthy adults
Adult |
Others
NO
To prove the effect of salmon milt DNA-Na on liver function associated with 12 week daily intake in a randomized, double-blind, placebo-controlled, parallel group study.
Safety,Efficacy
Confirmatory
Pragmatic
ALT at 4, 8 and 12 weeks after beginning the intake of test food.
AST, gamma-GTP, ALP, LDH, ChE, AST/ALT ratio, TIBC, UIBC, ferritin, L/S ratio, TP, Alb, A/G ratio, TNF-alpha, IL-1 beta, IL-6, body weight, body fat rate, BMI, adiponectin, leptin, blood RNA
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
YES
Central registration
2
Treatment
Food |
Daily intake of 4 tablets of salmon milt DNA-Na for 12 weeks.
Daily intake of 4 tablets of dextrin for 12 weeks.
30 | years-old | <= |
70 | years-old | > |
Male and Female
1.Subjects who agree to participate in this study with a written informed consent.
2.Subjects whose ALT level is >=25 U/l and <100 U/l (men), >=17 U/l and <100 U/l (women).
3.Subjects whose BMI is >=23 kg/m2 and <30 kg/m2.
1.Subjects who are under physician's advice, treatment, and/or medication for, hyperuricemia and/or dyslipidemia.
2.Subjects with hepatic diseases except NAFLD (such as NASH, hepatitis C, hepatitis B, autoimmune hepatitis, liver cirrhosis and liver cancer etc).
3.Subjects whose UA level is not less than the reference value (>= 7.1 mg/dl).
4.Subjects whose AST level is >=100 U/l.
5.Subjects who use pacemaker or defibrillator.
6.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
7.Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
8.Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
9.Subjects with severe anemia.
10.Pre- or post-menopausal women complaining of obvious physical changes.
11.Subjects who are at risk of having allergic reactions to drugs or foods, especially salmon and/or milt.
12.Subjects who regularly take medicine, functional foods, and/or supplements which would affect liver function.
13.Subjects who regularly take medicine, functional foods, and/or supplements which would affect lipid metabolism.
14.Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
15.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.
16.Pregnant or lactating women or women who expect to be pregnant during this study.
17.Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
18.Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
50
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 Research Center
069-8585
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
Maruha Nichiro Corporation, Central Research Institute
Profit organization
Japan
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 | 25 | Day |
Unpublished
Completed
2018 | Year | 09 | Month | 25 | Day |
2018 | Year | 09 | Month | 25 | Day |
2018 | Year | 11 | Month | 28 | Day |
2019 | Year | 03 | Month | 20 | Day |
2019 | Year | 06 | Month | 04 | Day |
2019 | Year | 06 | Month | 11 | Day |
2019 | Year | 09 | Month | 30 | Day |
2018 | Year | 10 | Month | 24 | Day |
2019 | Year | 11 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039455
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