KCT0008095
Completed
未知
A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of PB1 on Reducing Body Fat
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kangbuk Samsung Medical Center
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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