None listed
Conditions
Interventions
Dietary Supplement : - Main ingredient: Lactiplantibacillus plantarum GBCC_F0227 Probiotics(experimental) or Maltodextrin(placebo comparator)
- Properties and Formulation: A white capsule containing a
Sponsors
GI Biome
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects between the ages of 19 and less than 65 2) Subjects with a body mass index (BMI) of 25 kg/m^2 or more and less than 30 kg/m^2 3) Subjects who consented to participate in this study and voluntarily signed a written consent form
Exclusion criteria
Exclusion criteria: 1) Subjects currently undergoing treatment for severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary, renal and urinary, nervous, psychiatric, infectious diseases, or malignant tumors. 2) Subjects with a history of general anesthesia surgery or obesity-related procedures within 6 months prior to Visit 1 (however, for obesity surgeries(e.g., gastric banding, sleeve gastrectomy, gastric bypass), within 1 year). 3) Subjects who have used the following medications within 1 month (30 days) prior to Visit 1 ? Obesity treatment medications (appetite suppressants, fat absorption inhibitors, GLP-1 receptor agonists, etc.) ? Psychiatric medications for depression, schizophrenia, etc. ? Beta-blockers, diuretics, systemic steroids (sex hormones, adrenal corticosteroids), contraceptives, thyroid hormones, hormone blockers, immunosuppressants, proton pump inhibitors ? Hyperlipidemia medications, blood lipid and cholesterol-improving supplements (e.g., omega-3 (EPA and DHA-containing oils), indigestible maltodextrin, gamma-linolenic acid-containing oils, lecithin, plant sterols, etc.) ? Weight control-related health supplements, herbal medicine, and weight control-specific dietary products 4) Subjects who have used the following medications or foods within 2 weeks prior to Visit 1 ? Systemic antibiotics, systemic antimicrobials ? Digestive aids ? Probiotics, prebiotics ? Probiotic products taken continuously (4 times a week or more) 5) Subjects with uncontrolled hypertension (systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher, measured after 10 minutes of rest). 6) Subjects with fasting blood glucose levels of 126 mg/dL or higher, or those receiving antidiabetic medications (oral hypoglycemic agents, insulin, etc.). 7) Subjects with a TSH level outside the normal range of the testing facility (however, participation may be allowed based on the judgment of the investigator, considering the subject's condition). 8) Subjects with an eGFR below 60 mL/min/1.73 m². 9) Subjects with AST (GOT) or ALT (GPT) levels more than three times the upper normal limit of the testing facility. 10) Subjects with a history of alcohol abuse or chronic alcohol consumption. 11) Heavy smokers (smoking more than 20 cigarettes per day). 12) Subjects who are unable to exercise due to musculoskeletal disorders. 13) Subjects who have experienced a weight change of more than 10% or more than 5 kg within 3 months prior to Visit 1. 14) Subjects who have participated in a commercial obesity program within 3 months prior to Visit 1. 15) Subjects who have given birth within 6 months prior to Visit 1. 16) Pregnant, breastfeeding subjects, or those planning pregnancy during the clinical trial period. 17) Subjects with severe gastrointestinal disorders that would cause problems with consuming the trial product. 18) Subjects who have participated in another interventional clinical trial (including human trials) within 3 months prior to Visit 1, or those planning to participate in another interventional clinical trial (including human trials) after the start of this clinical trial. 19) Subjects who are sensitive or allergic to the ingredients in the trial product. 20) Other subjects whom the investigator deems unsuitable for participation due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body fat mass evaluated by DEXA | — |
Secondary
| Measure | Time frame |
|---|---|
| body fat percentage, lean mass evaluated by DEXA; body weight, body mass index(BMI);waist circumference, hip circumference, waist/hip circumference ratio;total abdominal fat area, visceral fat area, subcutaneous fat area, visceral/subcutaneous fat area ratio evaluated by CT;Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride;Insulin, Glucose;Safety Endpoints(Adverse Event, Clinical Laboratory Exam, Vital Sign(Blood Pressure, Pulse)) | — |
Countries
Korea, Republic of
Contacts
Public ContactByun Hyeyoung
Kangbuk Samsung Medical Center
Outcome results
None listed