UMIN-CTR Clinical Trial
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|Unique ID issued by UMIN||UMIN000025849|
|Scientific Title||Effect of Intake Time of Fish Oil (DHA & EPA) on Serum Lipids in Healthy Adults: A Randomized, Placebo-Controlled, Parallel Group Trial|
|Date of disclosure of the study information||2017/01/26|
|Last modified on||2017/12/14|
|Public title||Effect of Intake Time of Fish Oil (DHA & EPA) on Serum Lipids in Healthy Adults: A Randomized, Placebo-Controlled, Parallel Group Trial|
|Acronym||Effect of Intake Time of Fish Oil (DHA & EPA) on Serum Lipids in Healthy Adults: A Randomized, Placebo-Controlled, Parallel Group Trial|
|Condition||N/A (healthy adults)|
|Classification by specialty||
|Classification by malignancy||Others|
|Narrative objectives1||This trial aims effects and safety of intake time of sausage added fish oil (DHA & EPA) on blood fatty acid, blood triglycerides, and hepatic gene expression involved in lipid metabolism.|
|Basic objectives -Others|
|Primary outcomes||Blood fatty acid fracitionation (Week 0, Week 4, Week 8)|
|Key secondary outcomes||*Secondary outcomes
Gene expression (hepatic gene involved in lipid metabolism, clock gene, housekeeping gene) (Week 0, Week 4, Week 8)
Triglyceride (Screening, Week 0, Week 4, Week 8)
Insulin (Week 0, Week 4, Week 8)
Glycoalbumin (Week 0, Week 4, Week 8)
Total cholesterol (Week 0, Week 4, Week 8)
LDL cholesterol (Week 0, Week 4, Week 8)
HDL cholesterol (Week 0, Week 4, Week 8)
Blood pressure (Screening, Week 0, Week 4, Week 8)
Weight, body fat percentage, BMI (Screening, Week 0, Week 4, Week 8)
Blood test (adiponectin) (Screening, Week 0, Week 4, Week 8)
Blood biochemical test (Screening, Week 0, Week 4, Week 8)
Urine analysis (Screening, Week 0, Week 4, Week 8)
Doctor's questions (Screening, Week 0, Week 4, Week 8)
Subject's diary (From the first day of ingestion of a test material to the last day of the test)
Blood fatty acid fracitionation (DHA, EPA, DHLA, AA) (Screening)
Blood-borne infection (Screening)
|Blinding||Double blind -all involved are blinded|
|No. of arms||2|
|Purpose of intervention||Treatment|
|Type of intervention||
|Interventions/Control_1||Oral intake of sausage added fish oil (DHA & EPA) at breakfast or dinner (1 piece per a day [50g] ; 8 weeks)|
|Interventions/Control_2||Oral intake of sausage not added fish oil (DHA & EPA) at breakfast or dinner (1 piece per a day [50g] ; 8 weeks)|
|Gender||Male and Female|
|Key inclusion criteria||Males and Females aged 20-60 years.
Individuals who are healthy and don't receive treatment.
Individuals whose written informed consent has been obtained.
Individuals who can have an examination in a designated day.
Individuals who can stop intaking blue-backed fishes (tuna, saury, horse mackerel, mackerel, yellowtail, seriola; including processed foods like canned food) during the test period.
Individuals judged appropriate for the trial by the principal.
|Key exclusion criteria||Individuals using medical products.
Individuals who use a drug for treatment of disease.
Individuals who are patient or have a history of hyperlipidemia, high blood pressure, diabetes, psychiatric disease, and sleep disorder.
Individuals who have a custom to intake blue-backed fishes (tuna, saury, horse mackerel, mackerel, yellowtail, seriola; including processed foods like canned food) over 3 days per a week.
Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis).
Individuals who have a history of heart failure, kidney failure, hepatitis B or hepatitis C.
Individuals who have a history of digestive system disease.
Individuals whose BMI is over 30.
Individuals whose blood neutral lipid is over 200mg/dL.
Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
Individuals who are a smoker.
Individuals with serious anemia.
Individuals who are sensitive to a test product or other foods, and medical products.
Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 1 month or will ingest those foods during the test period.
Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
Individuals who are or are possibly, or are lactating.
Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
Individuals who participated in other clinical studies in the past 3 months.
Individuals who are or whose family is a employee of a health food, functional food, or cosmetic company.
Individuals judged inappropriate for the trial by the principal.
|Target sample size||20|
|Research contact person|
|Name of lead principal investigator||
|Organization||Medical Corporation Meiseikai, Higashi Shinjuku Clinic|
|Address||1-11-3 Okubo Shinjuku-ku Tokyo 169-0072, JAPAN|
|Name of contact person||
|Organization||TES Holdings Co., Ltd|
|Division name||Administrative Department of Clinical Trials|
|Address||6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN|
|Institute||TES Holdings Co., Ltd|
|Organization||Maruha Nichiro Corporation|
|Category of Funding Organization||Profit organization|
|Nationality of Funding Organization|
|Other related organizations|
|Name of secondary funder(s)|
|IRB Contact (For public release)|
|Org. issuing International ID_1|
|Org. issuing International ID_2|
|IND to MHLW|
|Other administrative information|
|Date of disclosure of the study information||
|URL releasing protocol|
|Publication of results||Unpublished|
|URL related to results and publications|
|Number of participants that the trial has enrolled|
|Results date posted|
|Results Delay Reason|
|Date of the first journal publication of results|
|Plan to share IPD|
|IPD sharing Plan description|
|Date of protocol fixation||
|Date of IRB|
|Anticipated trial start date||
|Last follow-up date|
|Date of closure to data entry|
|Date trial data considered complete|
|Date analysis concluded|
|Other related information|
|Last modified on||
|Link to view the page|
|Registered date||File name|
|Research case data specifications|
|Registered date||File name|
|Research case data|
|Registered date||File name|