None listed
Conditions
Interventions
Dietary Supplement : Take test food(2.5 x 10 10 cells/day as a Lactiplantibacillus plantarum L-14 heat treatment culture dry matter(L14)) or placebo (400 mg/capsule as dextrin) once a day, 1 capsule,
Sponsors
Global Medical Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person aged 19 or older and less than 65 years of age 2) Those with a body mass index (BMI) of 25 kg/m² or more and less than 30 kg/m² for visit 1 and visit 2 3) A person who agrees to participate in the human body application test and prepares a written consent form before the human body application test begins
Exclusion criteria
Exclusion criteria: 1) Serious cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary tract, kidney and urinary system, nervous system, mental, A person who is currently being treated for infectious disease and malignant tumors(but may participate in the test at the discretion of the tester considering the condition of the test subject to the human body application test) 2) A person who has a surgical history through general anesthesia within 6 months based on visit 1{However, in the case of obesity surgery (gastric band plastic surgery, gastric sleeve resection, gastric bypass surgery, etc.), within one year} 3) A person who has experience in diet, such as low-carbohydrate, intermittent fasting, etc., within three months based on visit 1 4) A person who has used subcutaneous injections (heparin, insulin) within one year on the basis of visit 1 5) A person who has used the following drugs within one month (30 days) based on visit 1 ? Obesity drugs (food intake inhibitors, fat absorption inhibitors, GLP-1 receptor agonists, etc.) ? psychiatric drugs such as depression and schizophrenia ? Beta blockers, diuretics, female hormones, male hormones, thyroid hormones, systemic corticosteroids, immunosuppressants, proton pump inhibitors, hydrogen blockers, nonsteroidal anti-inflammatory drugs ? Hyperlipid drugs, blood lipids and cholesterol-improving health functional foods [Omega 3 (maintained containing EPA and DHA), ovarian-oxidizing maltodextrin, gamma-linolenic acid, lecithin, plant cholesterol, etc.] ? Health functional foods/supplements for weight control purposes, herbal medicines, and preparation foods for weight control 6) A person who has administered systemic antibiotics, systemic antibacterial agents, and intestinal drugs within two weeks of visit 1 7) A person who has consumed probiotics, prebiotics, fermented milk and lactobacillus products continuously (more than four times a week) within two weeks of visit 1 8) Uncontrolled hypertension patients (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg, and measurement criteria after 10 minutes of stabilization of test subjects) 9) Diabetes patients with fasting blood sugar of 126 mg/dL or more or who are on antidiabetic medications (such as oral hypoglycemic agents, insulin, etc.) 10) TSH is outside the normal range of the implementing institution 11) Those with eGFR less than 60 mL/min/1.73 m² 12) A person whose AST (GOT) or ALT (GPT) is three times or more than the upper limit of the normal limit of the implementing institution 13) A person who has a history of alcohol abuse or is chronically consuming alcohol* An average of 40 g or more (280g/week) per day for men and 20 g or more per day for women (140g/week) 14) Excessive smokers (20 or more per day) 15) A person deemed unable to exercise due to musculoskeletal disorders 16) A person who has a weight change of 10% or more or 5 kg or more within 3 months of visit 1 17) A person who has participated in a commercial obesity program within three months on the basis of visit 1 18) A person who has given birth within six months as of visit 1, is pregnant, is nursing, or has a pregnancy plan during the main human body application test period 19) A person who has a problem with eating food for human application testing due to severe gastrointestinal disorders 20) A person who has participated in other interventional clinical trials (including human
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of body fat through DEXA | — |
Secondary
| Measure | Time frame |
|---|---|
| Body fat percentage, the amount of fat in one's body;body weight, body mass index;waist circumference, hip circumference, waist/hip circumference ratio;Total abdominal fat area, visceral fat area, subcutaneous fat area, visceral fat/subcutaneous fat area ratio through CT;blood lipid(Total cholesterol, Triglyceride, HDL-cholesterol, LDL-cholesterol);blood index(hs-CRP) | — |
Countries
Korea, Republic of
Contacts
Public ContactChae Min Baeg
Global Medical Research Center
Outcome results
None listed