A 12 week, Multi-center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of BM_WL on Reducing Body Fat
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0009235
- Lead Sponsor
- Kwang Dong Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1) A person who is 19 years of age or older and 65 years of age or younger
2) Those with a body mass index (BMI) of 23 kg/m2 or more and less than 30 kg/m2 in Visit 1 and Visit 2
3) A person who agrees to participate in this human body application test before the human body application test begins and prepares a written consent form.
1) Severe cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary system, kidney and urinary system, nervous system, mental, infectious disease, and malignant tumor can participate in the test at the discretion of the tester.
2) Those diagnosed with cancer within 5 years of visiting 1 [(excluding thyroid cancer and early cervical cancer (epithelial cancer))
3) Within one month (30 days) of visit, weight-affecting drugs (obesity drugs, liposuction inhibitors, GLP-1 receptor agonists, etc.), psychiatric drugs such as depression and schizophrenia, beta blockers, diuretics, contraceptives, steroids, female hormones, thyroid hormones}, hyperlipidemia drugs (including omega-3s), health functional foods/supplements for weight control, herbal medicines and weight control preparations, and health functional foods for improving blood lipids and cholesterol (maintenance of EPA and DHA, maintenance of ovarian maltodextrin, gamma-linolenic acid, lecithin, plant cholesterol, etc.)
4) A person who has undergone obesity surgery within one year based on visit 1.
5) Patients 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 for those subject to human application tests)
6) Diabetes patients with fasting blood sugar of 126 mg/dL or higher or taking anti-diabetic drugs (such as oral hypoglycemic drugs, insulin, etc.).
7) Those whose TSH is outside the normal range of the implementing institution (however, in consideration of the condition of the person subject to the human body application test) may participate in the test at the discretion of the tester.)
8) Those with a creatine level of at least twice the normal upper limit of the implementing institution.
9) Those whose AST (GOT) or ALT (GPT) is at least three times the normal upper limit of the agency.
10) Alcohol use ? Those with induction disorders and central nervous disorders
11) A person who is deemed unable to exercise due to musculoskeletal disorders.
12) A person who has a weight change of 10% or more within three months based on visit 1
13) A person who has participated in a commercial obesity program within 3 months of visiting 1
14) A person who is pregnant or who is lactating or has plans to conceive during this human body application test.
15) A person who has a problem eating food for human application testing due to severe gastrointestinal disorders
16) A person who has participated in another interventional clinical trial (including the human body application test) within 3 months of visit 1 or plans to participate in another interventional clinical trial (including the human body application test) after the start of this human body application test
17) A person who is sensitive to or allergic to food ingredients for this human body application test
18) A person who is deemed inappropriate 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 percentage through DEXA
- Secondary Outcome Measures
Name Time Method Weight;Body mass index (BMI);Waist circumference, hip circumference, waist/hip circumference ratio;Body fat control through DEXA;Visceral fat, subcutaneous fat, total abdominal fat area, and visceral/subcutaneous fat area ratio through CT;blood lipids(Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride Free Fatty Acid);Adiponectin