Human trial study to evaluate the efficacy and safety of TZ-DTP on decrement of body fat
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0006059
- Lead Sponsor
- Teazen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 100
1) Male or female subjects aged from 19 to 70 years old
2) BMI of 25 to <30 kg/m2
3) Satisfied with 1), 2) and subjects who decided to voluntarily participate in this clinical trial and complete to sign on the informed consent
1) Participants with intentional weight loss of at least 10% within 3 months prior to screening
2) Subjects who have experience in influencing the interpretation of the results of this study, such as carbohydrates and lipid metabolism, drugs that can affect weight and hormones, or health functional foods within the last two months.
3) Subjects with acute severe cardiovascular disease such as heart failure, myocardial infarction, stroke, etc.
4) Subjects who in which the local or the systemic inflammatory immune disease including the rheumatoid arthritis, the autoimmune disease etc.
5) Subjects who have clinically significant hypersensitivity history due to drug, experimental product or ingredients
6) Subjects who have a medical history of gastrointestinal diseases(Crohn's disease, etc.) or operation(except appendectomy or herniotomy)
7) Participation in other clinical trials within the previous three months
8) Subjects with kidney disease, such as acute/chronic renal failure, nephrotic syndrome, etc
9) Subjects who has received antipsychotic treatment within two months before screening test
10) Subjects with reduced liver or kidney function
? AST, ALT > 3 times the upper limit of normal
? Creatinine = 2.0mg/dL
11) Subjects who are suspected drug abuse or have a medical history of dependent on drug
12) Subjects who are pregnant and breastfeeding female
13) Pregnant women, lactating women or women in childbearing age who are not willing to accept contraception during clinical trials(except woman who undergo sterilization operation)
14) Subject with hypersensitivity to the ingredients contained in a clinical product
15) Subject who takes diabetes and diabetes drugs
16) Uncontrolled hypertension (blood pressure = 160/100 mmHg)
17) Subject who deemed inappropriate to participate this clinical trial by research director due to other reasons including screening test
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fat mass, Percent Body Fat, Lean Mass by DEXA(Dual-energy X-ray absorptiometry) Dual Energy X-ray Absorptiometry
- Secondary Outcome Measures
Name Time Method Visceral Fat Area, Subcutaneous Fat Area, Taoal Fat Area,Visceral fat / Subcutanesou Fat Ratio by CT;Body mass index;waist circumference, hip circumference, waist circumference/hip circumference ratio;Adipokine(leptin, adiponectin)