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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034627
Receipt No. 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 2019/04/12

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Basic information
Public title Effect of Daily Intake of Salmon Milt DNA-Na on Liver Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study (Confirmatory Trial)
Acronym Beneficial Effects of Salmon Milt DNA-Na on Liver Function
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)
Scientific Title:Acronym Beneficial Effects of Salmon Milt DNA-Na on Liver Function
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes ALT at 4, 8 and 12 weeks after beginning the intake of test food.
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Daily intake of 4 tablets of salmon milt DNA-Na for 12 weeks.
Interventions/Control_2 Daily intake of 4 tablets of dextrin for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key 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.
Key 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.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name NISHIHIRA
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code 069-8585
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name Jun
Middle name
Last name NISHIHIRA
Organization Hokkaido Information University
Division name Health Information Science Research Center
Zip code 069-8585
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization Maruha Nichiro Corporation, Central Research Institute
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The ethics committee of Hokkaido Information University
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel 011-385-4411
Email soumu@do-johodai.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北海道情報大学 保健センター(北海道)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 09 Month 25 Day
Date of IRB
2018 Year 09 Month 25 Day
Anticipated trial start date
2018 Year 11 Month 28 Day
Last follow-up date
2019 Year 03 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 24 Day
Last modified on
2019 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039455

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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