None listed
Conditions
Interventions
Others(health functional food) : Test group 1(Low-dose group): FJH-KO (Kril-oil 375 mg/capsule)
Test group 2(High-dose group): FJH-KO (Kril-oil 750 mg/capsule)
Control group: placebo of FJH-KO
Ingesti
Sponsors
FromBIO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult male and female subjects aged 19 to 70 years at the time of screening 2) Adult male and female subjects with a platelet aggregation response time of 68–142 seconds 3) Subjects who are capable of understanding and complying with the study procedures and requirements as described in the human application study protocol 4) Subjects who voluntarily agree to participate in this human application study and provide written informed consent by signing the informed consent form (ICF)
Exclusion criteria
Exclusion criteria: 1) Subjects with a current or previous history of the following diseases*: Leukemia, autoimmune diseases, systemic inflammatory diseases, or infectious diseases 2) Subjects with a current or previous history of acute or chronic heart failure, myocardial infarction, cerebrovascular disease, atherosclerosis, gastrointestinal diseases (e.g., Crohn’s disease, irritable bowel syndrome, history of gastrointestinal resection), hepatic, renal, or thyroid diseases 3) Patients with cancer 4) Subjects with diseases associated with bleeding 5) Subjects with thyroid or hormonal abnormalities or abnormal thyroid function test results 6) Subjects with neurological or psychiatric disorders (e.g., depression, schizophrenia) or a history of psychological or psychiatric treatment 7) Subjects who have undergone surgery* within the past 6 months: Including cardiovascular disease–related surgery, arrhythmia, heart failure, myocardial infarction, pacemaker implantation, arterial angioplasty, or coronary artery bypass surgery 8) Subjects with allergic diseases (e.g., anaphylaxis, atopic dermatitis, drug allergies) 9) Subjects currently taking medications that may affect blood lipid levels 10) Subjects currently taking medications that may affect autonomic or cardiovascular function 11) Subjects currently taking statin-related medications, antibiotics, anticoagulants, or nonsteroidal anti-inflammatory drugs (NSAIDs) 12) Subjects with uncontrolled hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg) 13) Subjects with diabetes mellitus* (HbA1c > 7.0%): Including those receiving antidiabetic medications (oral hypoglycemic agents, insulin, etc.) 14) Subjects with hyperlipidemia* : Total cholesterol = 250 mg/dL or LDL cholesterol = 190 mg/dL 15) Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use appropriate contraception during the study period or who are planning pregnancy 16) Subjects with known allergies or adverse reactions to the main ingredient or any component of the investigational food ? Main ingredient: Krill oil (intake restricted in individuals with crustacean or shellfish allergies) 17) Subjects with a history of or suspected drug abuse or substance dependence 18) Subjects with alcohol dependence or habitual alcohol consumption exceeding the following amounts: ? Men: > 40 g/day (approximately 4 glasses of beer or 4 shots of soju) ? Women: > 20 g/day (approximately 2 glasses of beer or 2 shots of soju) 19) Subjects who are heavy smokers (= 20 cigarettes per day) 20) Subjects who have taken health functional foods or medications related to circulation improvement within 3 months prior to the screening visit* - Antiplatelet agents (e.g., clopidogrel, aspirin) - Medications affecting blood lipid levels (e.g., statins, fibrates) - Anticoagulants (e.g., warfarin, enoxaparin, Astrix) - Nonsteroidal anti-inflammatory drugs (NSAIDs), except acetaminophen (Tylenol) - Health functional foods including red ginseng, coenzyme Q10, omega-3 fatty acids, Ginkgo biloba extract, Ganoderma lucidum fruiting body extract, gamma-linolenic acid–containing oils, Bacillus natto culture, L-arginine, PME-88 melon extract, cocoa powder, Pycnogenol® (French maritime pine bark extract), grape leaf extract, refined squid oil, etc. 21) Subjects who have participated in or plan to participate in another human application study or clinical trial within 3 months prior to screening 22) Subjects with abnormal clini
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet aggregation response | — |
Secondary
| Measure | Time frame |
|---|---|
| Vascular elasticity: pulse wave velocity (PWV), blood pressure;Platelet activation and blood coagulation: serotonin, thromboxane B2(TXB2), prostacyclin (PGI);Endothelial cell activation: Platelet Selectin(P-selectin), Endothelial Selectin(E-selectin), Intercellular Adhesion Molecule(ICAM)-1, Vascular Cell Adhesion Molecule(VCAM)-1, Tumor necrosis Factor(TNF)-a, Interleukin-6, Interleukin-1ß;Vasoconstriction and vasodilation: nitric oxide (NO);Fibrinolysis: plasminogen;Subject-reported subjective assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactMisuk Kang
Hallym University Medical Center
Outcome results
None listed