None listed
Conditions
Interventions
Dietary Supplement : Subjects who meet the screening criteria are randomized into either the probiotic group or the placebo group. Participants consumed two capsules of either the probiotic or placebo
Sponsors
Vievis Namuh Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who are adult men and women between 19~70 years of age 2) Serum triglyceride levels of 150 mg/dL~199 mg/dL, or serum triglyceride levels of 120 mg/dL~149 mg/dL with total cholesterol levels of 200 mg/dL~239 mg/dL 3) Subjects who agree to the participation in the trial and submit informed consent before the beginning of the trial
Exclusion criteria
Exclusion criteria: 1) Subjects who are currently being treated for severe diseases including cardiovascular (myocardial infarction, etc.), immune, respiratory, gastrointestinal/hepatobiliary, renal/urinary, nervous (stroke, etc.), musculoskeletal, psychiatric, infectious diseases, and malignant tumors 2) BMI of Visit 1, is less than 20 kg/m2 or more than 35 kg/m2 3) Subjects who used the following drugs or foods within 2 months prior to Visit 1: ? Hormonal agents (including oral contraceptives) ? Medications that may affect lipid metabolism (Statins, Omega-3 fatty acid, Nicotinic acid, Acipimox, Fibrates, Thiazide, Beta blockers, etc.) (However, Thiazide and Beta blockers are allowed if there was no dose change within 1 year of Visit 1 and no change is expected during the trial) ? Health functional foods that may affect lipid metabolism (Omega-3, Digestion-resistant maltodextrin, Gamma-linolenic acid, Lecithin, Lactiplantibacillus plantarum Q180, etc.) 4) Subjects who took antibiotics, intestinal regulators, probiotics, prebiotics, or lactic acid bacteria products within 2 weeks prior to Visit 1 5) Subjects with the following diseases or history: ? Familial hypercholesterolemia ? Drug addiction 6) History of gastrointestinal surgery (Excluding polypectomy, appendectomy, and cholecystectomy; other surgeries may be allowed at the investigator's discretion) 7) Uncontrolled hypertension (Systolic BP = 140 mmHg or Diastolic BP = 90 mmHg after 10 minutes of rest) 8) Diabetic patients with HbA1c = 6.5% or those taking anti-diabetic medications (oral hypoglycemic agents, insulin, etc.) 9) Subjects with hyperthyroidism or hypothyroidism 10) eGFR less than 60 mL/min/1.73m2 11) AST (GOT) or ALT (GPT) levels more than 3 times the upper limit of normal at the trial site 12) History of alcohol abuse or chronic alcohol consumption* *Men: average = 40 g/day (280 g/week), Women: average = 20 g/day (140 g/week) 13) Heavy smokers (20 or more cigarettes per day) 14) Pregnant, lactating women, or those planning to become pregnant during the trial 15) Subjects with difficulty consuming the trial food due to severe gastrointestinal disorders 16) Participation in other interventional clinical trials within 3 months prior to Visit 1, or planning to participate during this trial 17) Sensitivity or allergy to the ingredients of the trial food 18) Subjects judged by the investigator to be inappropriate for this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting serum triglyceride;Adverse Event | — |
Secondary
| Measure | Time frame |
|---|---|
| Total cholesterol;LDL-cholesterol;HDL-cholesterol;Clinical Pathology Tests (Hematological, Blood Chemistry, Urinalysis);Vital Signs (Blood Pressure, Pulse) | — |
Countries
Korea, Republic of
Contacts
Public ContactWooKil Jung
Vievis Namuh Hospital
Outcome results
None listed