N/A (healthy adults)
Conditions
Interventions
Oral intake of sausage added fish oil (DHA &
EPA) at breakfast or dinner (1 piece per a day [50g]
8 weeks)
Oral intake of sausage not added fish oil (DHA &
Sponsors
TES Holdings Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Males and Females aged 20-60 years. [2]Individuals who are healthy and don't receive treatment. [3]Individuals whose written informed consent has been obtained. [4]Individuals who can have an examination in a designated day. [5]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. [6]Individuals judged appropriate for the trial by the principal.
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products. [2]Individuals who use a drug for treatment of disease. [3]Individuals who are patient or have a history of hyperlipidemia, high blood pressure, diabetes, psychiatric disease, and sleep disorder. [4]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. [5]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [6]Individuals who have a history of heart failure, kidney failure, hepatitis B or hepatitis C. [7]Individuals who have a history of digestive system disease. [8]Individuals whose BMI is over 30. [9]Individuals whose blood neutral lipid is over 200mg/dL. [10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [11]Individuals who are a smoker. [12]Individuals with serious anemia. [13]Individuals who are sensitive to a test product or other foods, and medical products. [14]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. [15]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [16]Individuals who are or are possibly, or are lactating. [17]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [18]Individuals who participated in other clinical studies in the past 3 months. [19]Individuals who are or whose family is a employee of a health food, functional food, or cosmetic company. [20]Individuals judged inappropriate for the trial by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Blood fatty acid fracitionation (Week 0, Week 4, Week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]Gene expression (hepatic gene involved in lipid metabolism, clock gene, housekeeping gene) (Week 0, Week 4, Week 8) [2]Triglyceride (Screening, Week 0, Week 4, Week 8) [3]Insulin (Week 0, Week 4, Week 8) [4]Glycoalbumin (Week 0, Week 4, Week 8) [5]Total cholesterol (Week 0, Week 4, Week 8) [6]LDL cholesterol (Week 0, Week 4, Week 8) [7]HDL cholesterol (Week 0, Week 4, Week 8) *Safety [1]Blood pressure (Screening, Week 0, Week 4, Week 8) [2]Weight, body fat percentage, BMI (Screening, Week 0, Week 4, Week 8) [3]Blood test (adiponectin) (Screening, Week 0, Week 4, Week 8) [4]Blood biochemical test (Screening, Week 0, Week 4, Week 8) [5]Urine analysis (Screening, Week 0, Week 4, Week 8) [6]Doctor's questions (Screening, Week 0, Week 4, Week 8) [7]Subject's diary (From the first day of ingestion of a test material to the last day of the test) *Other indexes [1]Blood fatty acid fracitionation (DHA, EPA, DHLA, AA) (Screening) [2]Blood-borne infection (Screening) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd Administrative Department of Clinical Trials
Outcome results
None listed