Intervention Study to evaluate Body Fat Reduction Efficacy and Safety of 'BN-202M' in Overweight Subjects
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0007268
- Lead Sponsor
- Hecto Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1) A healthy male or female between the ages of 19 and 60
2) Subject with a BMI of 25kg/m2 or more and 29.9kg/m2 or less
3) Subject who voluntarily agreed in writing to participate in this human application test
1) Subject who has a history of hypersensitivity to raw materials or natural products in this study
2) Subject whose weight gain or loss within 3 months is 5 kg or more
3) Subject with excessive alcohol consumption (> 20 g/day)
4) Subject who have been diagnosed with dyslipidemia (hyperlipidemia) and cannot stop taking drugs that can affect lipid changes (bile acids, sequestrants, fibrates, niacin, statins, and steroids for systemic action)
(However, selection is possible after a wash-out period of 2 weeks or more has elapsed, and the period may vary by drug.)
5) Subject who have been receiving continuous treatment or medication for more than 10 days due to gastrointestinal disorders (gastric ulcer, chronic digestive disorder, etc.)
6) Subject with uncontrolled hypertension (sitSBP = 160 mmHg or sitDBP = 95 mmHg) or those taking diuretics and beta-blockers among high blood pressure medications
7) Diabetic patients taking oral hypoglycemic agents or insulin
8) Subject who have experience in surgery such as satellite type or intestinal resection or other surgical operations to lose weight within 6 months prior to screening
9) Subject who have taken drugs (including herbal medicines or health functional foods) that can affect body weight within 3 months prior to screening
(obesity drugs including absorption inhibitors and appetite suppressants, antidepressants, antipsychotics, contraceptives and female hormones, thyroid hormones, amphetamines, phenodiazine, cyproheptadine, etc.)
10) Subject with uncontrolled hyperthyroidism or hypothyroidism (TSH less than 0.1uU/ml or more than 10uU/ml)
11) Subject with clinically significant hematological, cardiac (congestive heart failure, ischemic heart disease, etc.), lung, neurological disease, or other serious systemic disorders
12) Subject with clinically significant renal dysfunction (serum creatinine of 1.5 mg/dl or more) or chronic renal failure
13) Subject with clinically significant liver dysfunction (at least one of ALT, AST, and ?-GT is 2.5 times higher than the upper limit of normal), liver cirrhosis, or chronic liver disease
14) Subject with a history of malignancy within 5 years prior to screening
15) Subject with eating disorders, psychotic disorders including depression, drug addicts
16) Subject suffering from autoimmune diseases
17) Subject suffering from anemia/porphyria
18) Pregnant and lactating women and women of childbearing potential who do not use an appropriate method of contraception (but cannot take oral contraceptives)
19) Subject who have participated or plan to participate in other clinical (human application) trials within 3 months prior to screening
20) In the opinion of the person in charge of study, those who are judged not to be able to comply with the study requirements or to be inappropriate
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in body fat percentage (%) through DEXA
- Secondary Outcome Measures
Name Time Method Change in weight (kg);Changes in body mass index (BMI);Changes in body fat mass (kg) through DEXA;Changes in lean mass (kg) through DEXA;Waist/hip circumference ratio (WHR) change;Changes in serum adiponectin concentration;Changes in serum Leptin concentration;Changes in serum insulin concentration;Changes in serum glucose concentration;Changes in serum lipid (Total cholesterol, HDL cholesterol, LDL cholesterol, Triglyceride) concentration