None listed
Conditions
Interventions
Dietary Supplement : Subjects will be randomly assigned to either the experimental group or the control group in the order of their registration. The assigned subjects will consume the investigational
Sponsors
CINNAMON LAB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women aged 19 years or older and under 70 years. 2) Individuals who meet at least three of the following criteria: ? Fasting Total Cholesterol between 200 and 239 mg/dL at Visit 1. ? Fasting LDL-Cholesterol between 130 and 159 mg/dL at Visit 1. ? Fasting blood glucose between 100 and 125 mg/dL at Visit 1. ? Systolic blood pressure between 120 and 139 mmHg at Visit 1. ? BMI between 25 kg/m² and 30 kg/m² at Visit 1. ? Waist-to-hip ratio (WHR) = 0.9 for men, = 0.85 for women at Visit 1. 3) Individuals who have voluntarily agreed to participate in the clinical trial and have signed the Informed Consent Form before the start of the trial.
Exclusion criteria
Exclusion criteria: 1) Individuals currently undergoing treatment for severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary, renal and urinary, neurological, endocrine, psychiatric, infectious diseases, or malignant tumors. 2) Individuals with heart failure, myocardial infarction, cerebrovascular disease, arteriosclerosis, hyperlipidemia, gastrointestinal diseases (e.g., Crohn’s disease), irritable bowel syndrome, leukemia, autoimmune diseases, inflammatory systemic diseases, or infectious diseases. 3) Individuals with bleeding-related disorders (e.g., idiopathic thrombocytopenic purpura, hemophilia, disseminated intravascular coagulation). 4) Individuals with neurological or psychiatric disorders (e.g., depression, schizophrenia) or who have received psychological treatment. 5) Individuals with a history of gastrointestinal surgery. 6) Individuals who have undergone cardiovascular-related procedures, including arrhythmia treatment, heart failure treatment, myocardial infarction, pacemaker implantation, angioplasty, or coronary artery bypass surgery within 6 months before Visit 1. 7) Individuals who have taken medications that may affect blood lipid levels, autonomic or cardiovascular functions, or blood flow improvement (e.g., antivirals, immunosuppressants, antipsychotics, anticonvulsants, antihypertensives such as calcium channel blockers, beta-blockers, ACE inhibitors, hormones such as corticosteroids or thyroid hormones, antiarrhythmics, antibiotics, anticoagulants, NSAIDs, SGLT2 inhibitors, thiazide diuretics, statins) within 4 weeks before Visit 1. 8) Individuals who have consumed the following foods within 4 weeks before Visit 1: ? Health supplements that may affect blood lipid levels, cardiovascular function, or blood flow improvement (e.g., DHA and EPA-containing oils, gamma-linolenic acid oils, ginseng extract, reishi mushroom extract, ginkgo biloba extract, vitamin E, L-arginine, shiitake mushroom extract, cocoa powder). ? Health supplements related to green tea extract or Artemisia annua extract. 9) Individuals who have experienced a weight change of more than 10% or are currently undergoing weight loss within 8 weeks before Visit 1. 10) Individuals who engage in high-intensity exercise (e.g., hiking, running, cycling, aerobics) regularly (more than 4 days per week). 11) Individuals who have smoked (including all types of tobacco) within 6 months before Visit 1. 12) Individuals who consume alcohol chronically*. * Men: average 40 g or more of alcohol per day (280 g/week), Women: average 20 g or more of alcohol per day (140 g/week). 13) Individuals with AST (GOT) or ALT (GPT) levels greater than three times the upper normal limit of the testing institution. 14) Individuals with TSH levels below 0.1 uIU/mL or above 5.6 uIU/mL. 15) Individuals with eGFR below 60 mL/min/1.73 m². 16) Individuals with uncontrolled diabetes (HbA1c greater than 7.0%). 17) Individuals with total cholesterol levels above 240 mg/dL or LDL cholesterol levels above 160 mg/dL. 18) Individuals with uncontrolled hypertension (systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg, measured 10 minutes after resting). 19) Pregnant or breastfeeding individuals, or individuals planning to become pregnant during the course of the trial. 20) Individuals who have given birth within 6 months before Visit 1. 21) Individuals who have participated in another interventional clinical trial (including
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet aggregation;Platelet Selectin(P-Selectin), Endothelial Selectin(E-Selectin), Soluble Intercellular Adhesion Molecule-1(sICAM-1), Soluble Vascular Cell Adhesion Molecule-1(sVCAM-1), Nitric Oxide(NO), Thromboxane A2;Blood pressure;Pulse Wave Velocity (PWV), Ankle-Brachial Index (ABI), Blood Flow(Blood Flow Volume, Blood Flow Velocity, Vessel Lumen Area);Total Cholesterol, Low-Density Lipoprotein Cholesterol(LDL-Cholesterol), High-Density Lipoprotein Cholesterol(HDL-Cholesterol), Triglyceride;Prothrombin Time(PT), Activated Partial Thromboplastin Time(aPTT);Adverse event;Clinical Laboratory Tests (Hematological, Biochemical, and Urinalysis);Vital Signs (Pulse), Anthropometric Measurement (Body Weight);Electrocardiogram | — |
Countries
Korea, Republic of
Contacts
Public ContactSeungjae Baek
Bestian Seoul Hospital
Outcome results
None listed