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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)

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034627
Enrollment
50
Registered
2018-10-25
Start date
2018-11-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Daily intake of 4 tablets of salmon milt DNA-Na for 12 weeks. Daily intake of 4 tablets of dextrin for 12 weeks.

Sponsors

Hokkaido Information University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
ALT at 4, 8 and 12 weeks after beginning the intake of test food.

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactJun NISHIHIRA

Hokkaido Information University Health Information Science Research Center

nishihira@do-johodai.ac.jp011-385-4430

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026