A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of EEIP on Reducing Body Fat
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0008259
- Lead Sponsor
- COSMAX BIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
1) Those who are over 19 years old and under 65 years old
2) Those with a body mass index (BMI) of 25 kg/m 2 or more and less than 32 kg/m 2 on visit 1 and visit 2
3) A person who agreed to participate in this human application test and filled out the written consent (Informed Consent Form) before the human application test started
1) Those currently undergoing treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary tract, kidney and urinary, nervous, psychiatric, infectious diseases and malignant tumors (however, considering the condition of the test subject, You can participate in the test at your discretion.)
2) Persons with alcohol use or induced disorders or central nervous disorders
3) Those who are judged to be unable to exercise due to musculoskeletal disorders
4) 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, Those who use diuretics, contraceptives, steroids, female hormones, thyroid hormones}, health functional foods/supplements for weight control purposes, herbal medicines, and weight control formulas
5) Subjects who have taken hyperlipidemia drugs within 1 month (30 days) of visit 1 or who have taken omega 3 within 2 weeks of visit 1
6) A person who has had a weight change of 10% or more within 3 months from visit 1
7) Those who participated in a commercial obesity program within 3 months of visit 1
8) A person whose creatinine is more than twice the upper limit of normal at the implementing institution
9) A person whose AST (GOT) or ALT (GPT) is more than 3 times the upper limit of normal
10) Uncontrolled hypertension patients (systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more, measurement criteria after subject resting for 10 minutes)
11) Diabetic patients with a fasting blood sugar of 126 mg/dL or higher or taking anti-diabetic drugs (oral hypoglycemic agents, insulin, etc.)
12) Those whose TSH is less than 0.1 µIU/mL or more than 10 µIU/mL
13) Those who have participated in other interventional clinical trials (including human trials) within 3 months of visit 1, or plan to participate in other interventional clinical trials (including human trials) after the start of this human trial
14) Pregnant or lactating women or those who plan to become pregnant during this human application test
15) Those who are sensitive or allergic to food ingredients for this human application test
16) Those who are judged unsuitable by the tester for other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body fat mass and body fat percentage through DEXA
- Secondary Outcome Measures
Name Time Method Weight;Body Mass Index(BMI);Waist circumference, Hip circumference, Waist/Hip ratio;Lean mass and Skeletal muscle through DEXA;Visceral fat area, Subcutaneous fat area, Total abdominal fat area, Visceral/Subcutaneous fat area ratio through CT;Blood Liqids: Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride;hs-CRP;Leptin, LP