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Effect of Daily Intake of Salmon Milt DNA-Na on Liver Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study (Confirmatory Trial)

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Healthy adults
Date of first enrollment	2018/11/28
Target sample size	50
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Daily intake of 4 tablets of salmon milt DNA-Na for 12 weeks. Daily intake of 4 tablets of dextrin for 12 weeks.

Outcome(s)

Primary Outcome	ALT at 4, 8 and 12 weeks after beginning the intake of test food.
Secondary Outcome	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

Key inclusion & exclusion criteria

Age minimum	30years-old
Age maximum	70years-old
Gender	Male and Female
Include criteria
Exclude criteria	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.