None listed
Conditions
Interventions
Others(Health Functional Food) : The detail consist of PB1 and the Placebo on this Clinical trial are showm as follows.
PB1: PB1 (fermentation metabolite produced by Lactiplantibacillus plantarum KM2
Sponsors
Kangbuk Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 19 or older and younger than 65 2) Body mass index (BMI) is more than 25 kg/m²and 35 kg/m² or less 3) A person who agreed to participate in this Clinical Study and filled out the written informed consent form.
Exclusion criteria
Exclusion criteria: 1) Those currently undergoing treatment for urinary system, nervous system, mental, infectious diseases, malignant tumors, etc. 2) Drugs that affect weight within 1 month (30 days) of visit 1, {anti-obesity drugs (appetite suppressants, fat absorption inhibitors, GLP-1 receptor agonists, etc.), psychiatric drugs such as depression and schizophrenia, beta-blockers, diuretics, birth control pills, steroids}, health functional foods/supplements for weight control purposes, herbal medicines, and weight control formulas. 3) Taken hyperlipidemia drugs within 1 month (30 days) from Visit 1 or who have taken omega-3 within 2 weeks from Visit 1. 4) Taken antibiotics within 2 weeks of visit 1. 5) Consumed probiotics, prebiotics, synbiotics and fermented products continuously (more than 4 times a week) within 2 weeks from visit 1. 6) Patients with uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg). 7) Diabetic patients with fasting blood sugar of 126 mg/dL or higher or taking antidiabetic drugs (oral hypoglycemic drugs, insulin, etc.) 8) A person with TSH is less than 0.1 µIU/mL or more than 10 µIU/mL 9) A person whose creatinine is more than twice the upper limit of the study institution. 10) A person whose AST (GOT) or ALT (GPT) is more than 3 times the upper limit of the study institution. 11) A person with alcohol use induced disorders or central nervous system disorders. 12) Judged to be unable to exercise due to musculoskeletal disorders. 13) A person who has had a weight change of 10% or more within 3 months from visit 1 14) Those who participated in a commercial obesity program within 3 months of visit 1 15) Those who have participated in another clinical trial within 1 month (30 days) of visit 1, or plan to participate in another clinical trial after the start of this Clinical trial. 16) Pregnant or lactating women and who plan to pregnant during this clinical trial. 17) A person who has sensitive or allergic with food ingredients in this clinical trial. 18) Who Judged unsuitable from the tester in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fat(kg), Fat(%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Weight;Body Mass Index;Blood pressure;Waist/Hip Circumference;BIA (Lean, Visceral fat);Fasting blood glucose;Blood Lipids(Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride) ;Cytokine(TNF-a, IL-10, IL-6, IFN-?) ;Microbiome | — |
Countries
Korea, Republic of
Contacts
Public ContactJAEHEON KANG
Kangbuk Samsung Medical Center
Outcome results
None listed