A 12 week, Multi-center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of PS01 on Reducing Body Fat

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

Inclusion Criteria

1) Adult male and female over the age of 19
2) Those with a body mass index (BMI) of 25 kg/m2 or more and less than 35 kg/m2 at Visits 1 and 2
3) A person who has consented to participate in this human application test before the start of the human application test and filled out the Informed Consent Form

Exclusion Criteria

1) Those currently receiving treatment for severe cardiovascular, immune, respiratory, hepatobiliary, renal and urinary systems, nervous system, musculoskeletal system, psychiatric, infectious disease, and malignant tumor
2) Drugs that affect body weight within 1 month (30 days) of visit 1 (obesity drugs (appetite suppressants, fat absorption inhibitors, GLP-1 receptor agonists, etc.), psychiatric drugs such as depression and schizophrenia, contraceptives, steroids Preparations, female hormones}, those who use health functional foods/supplements for weight control, herbal medicines, and formulas for weight control
3) Those who have received new beta-blockers or diuretics within 6 months of Visit 1, or those who are expected to change their dose during the trial period (However, if they are being administered without changing their dose from 6 months ago, they can participate)
4) Patients with uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg, measurement standard after 10 minutes of rest for human subjects)
5) Diabetic patients whose glycated hemoglobin is 7.0% or higher or who are taking antidiabetic drugs (oral hypoglycemic agents, insulin, etc.)
6) Those with TSH of 0.1 µIU/mL or less or 10 µIU/mL or more
7) Those with GFR (Glomerular Filtration Rate) less than 45 mL/min
8) Those whose AST(GOT) or ALT(GPT) is 3 times or more of the normal upper limit of the implementing institution
9) Those who have problems with food intake for human application tests due to severe gastrointestinal disorders
10) People with alcohol use-induced disorders and central nervous system disorders
11) Those who are judged unable to exercise due to musculoskeletal disorders
12) Those who have had a weight change of 10% or more within 3 months based on visit 1
13) Those who participated in a commercial obesity program within 3 months of visit 1
14) Those who have participated in other interventional clinical trials (including human trials) within one month (30 days) of Visit 1, or who plan to participate in other interventional clinical trials (including human trials) after the start of this human trial
15) Those who are pregnant, lactating, or planning to become pregnant during this human application test period
16) Those who are sensitive to or allergic to the food ingredients for this human application test
17) Those who are judged inappropriate by the investigator for other reasons

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body fat mass, body fat percentage through DEXA

Secondary Outcome Measures

Name	Time	Method
weight;Waist circumference, hip circumference, waist/hip ratio;Body Mass index; lean body mass through DEXA;Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride;hs-CRP;Adiponectin, Leptin

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