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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034538
Receipt No. 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

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Basic information
Public title Safety of Daily Ingestion of the Scallop Oil: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Acronym Safety of the Scallop Oil
Scientific Title Safety of Daily Ingestion of the Scallop Oil: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Scientific Title:Acronym Safety of the Scallop Oil
Region
Japan

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

Objectives
Narrative objectives1 To prove the safety of the scallop oil associated with 4 week daily ingestion in a randomized, double-blind, placebo-controlled, parallel group study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The pattern, severity and frequency of side effects related to ingestion of the test food during the ingestion period.
Key secondary outcomes 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).

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 Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Daily ingestion 3.0 g of the scallop oil for 4 weeks.
Interventions/Control_2 Daily ingestion 1.2 g of scallop oil and 1.8 g of the cooking oil for 4 weeks.
Interventions/Control_3 Daily ingestion 3.0 g of the cooking oil for 4 weeks.
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
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 39

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 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 Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Laboratory of Food and Nutritional Sciences, Faculty of Chemistry, Materials, and Bioengineering, Kansai University
Name of secondary funder(s) IHI Corporation

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 17 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 37
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 Completed
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 10 Month 16 Day
Last follow-up date
2018 Year 12 Month 06 Day
Date of closure to data entry
2018 Year 12 Month 21 Day
Date trial data considered complete
2019 Year 01 Month 10 Day
Date analysis concluded
2019 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2018 Year 10 Month 17 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039175

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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