None listed
Conditions
Interventions
Dietary Supplement : Subjects are randomly assigned to one of the two groups and take test and control foods twice a day (morning and evening) for 12 weeks, one tablet at a time orally.
-Test Food: US
Sponsors
Uscare Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Adult men and women aged 19 to 80 at the time of the screening visit 2)Subjects whose fasting blood triglyceride level is greater than or equal to 130 mg/dL and less than 400 mg/dL, who do not take medication and do not require medication prescription 3)Subjects who are capable of understanding and complying with the test method and progress of this study protocol 4)Subjects who voluntarily agree to participate in this study and who have agreed in writing to the informed consent form (ICF)
Exclusion criteria
Exclusion criteria: 1)Subjects who have continuously taken medications* or health functional foods* that affect lipid metabolism within 8 weeks prior to the screening visit * Statin-based, bile acid adsorbents, nicotinic acid, and fibric acid derivatives subjects ** Omega-3 fatty acids, plant sterols, indigestible maltodextrin, globin hydrolysis, etc 2)Subjects who have or have a history of clinically significant acute or chronic cardio-cerebrovascular (myocardial infarction, stroke), endocrine system (hyperthyroidism and hypothyroidism), immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric system, musculoskeletal system, inflammatory and hematologic/tumor diseases (malignant tumors) that require treatment 3)Subjects with hypertension (those with systolic blood pressure greater than 140mmHg or diastolic blood pressure greater than 90mmHg) 4)Subjects with diabetes (HbA1C > 7.0%) * subjects on antidiabetic medications (such as oral hypoglycemic agents and insulin) 5)Subjects with a history of gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of food for human application tests 6)Subjects who have received antipsychotic medication within 2 months prior to screening tests 7)subjects with familial hypercholesterolemia 8)Subjects who are pregnant and lactating women or women of childbearing age who do not intend to use appropriate contraception or plan to conceive during the trial period 9)Subjects with or suspected drug addiction and substance abuse history 10) Subjects who regularly engage in high-intensity exercise (10 hours/week or more) 11)Those who smoke excessively (=20 cigarettes/day) 12) Subjects who drink excessively (male =40g/day, female =20g/day) 13) Subjects who are allergic to and have side effects on ingredients contained in test and control foods 14) Subjects who have participated in other human body application and clinical trials or have plans to participate within the last one month 15) Subjects showing the following results in diagnostic test medical examination results - eGFR < 60 mL/min/1.73 m2 - AST, ALT = 3 times the reference value 16) Subjects deemed unsuitable for participation in the study by the principal investigator due to diagnostic laboratory test results or other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of triglycerides in fasting blood | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid metabolism parameters;Atherogenic index;high-sensitive CRP;Intima-Media Thickness;Blood pressure;Physical measurement index;Adverse event assessment;Clinical laboratory tests;Vital signs;Electrocardiogram;Physical examination | — |
Countries
Korea, Republic of
Contacts
Public ContactSun Mi O
Chung-Ang Univerisity Hospital
Outcome results
None listed