Efficacy and safety of DW2010 on reducing body weight and body fat in overweight subjects; Exploratory Clinical Trial
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0002577
- Lead Sponsor
- Dongwha Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 30
1) female subjects between 20-50years of age inclusive with no menopause
2) BMI of 25.0-29.9kg/m2
3) no drink alcohol at least 1 month and during Clinical Trial
4) Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.
1)The Patients with severe cerebrovascular disease, cardiac disease (If that patient's clinical status is stable, they can participate in the clinical trial according to investgator)
2)Subjects with systolicBP = 160 mmHg or diastolicBP = 100 mmHg and also taking a beta blocker or a hydragogue.
3)Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose = 126 mg/dL or random blood glucose = 200 mg/dL.
4)TSH(Thyroid Stimulating Hormone) value =0.1uU/ml or =10 uU/ml
5)Serum creatinine = 2 times the upper limit of normal.
6)Serum AST(Aspartate aminotransferase)/ALT(Alanine aminotransferase) = 3 times the upper limit of normal.
7)Subjects who complain gastrointestinal symptoms such as heartburn, dyspepsia
8)The patient who take the medicine that can affect the state of weight change (uptake inhibitors, appetite suppressant, Antipsychotics hydragogue, contraceptives, steroid, and female sex hormon) within recent 1 months.
9)The patient who take the probiotics consistently within recent 1 week.
10)Participation in commercial diet program within the 3 months prior to screening.
11)Participation in any clinical trail within the 1 month prior to screening or have a plan to participate in other clinical trial.
12)Subjects who get hospitalization, medications or rehabilitation treatments for Alcohol disorders, cardiovascular disease, disorder of central nervous system.
13)Subjects with the musculoskeletal disorders or restricted physical activity.
14)Woman who are pregnant of lactating or planning to pregnant
15)Subjects which in the opinion investigator could affect preclude evluation of response
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Chainge in fat percentage(by Dual Energy X-Ray Absorptiometry, DEXA)
- Secondary Outcome Measures
Name Time Method Body weight ;Waist circumference, Hip circumference, waist-hip ratio(WHR) ;Body mass index(BMI) ;Fat mass, Fat Free Mass(by Dual Energy X-Ray Absorptiometry, DEXA) ;Mesenteric fat area, Subcutaneous fat area, Total abdominal fat area, Mesenteric fat area/Subcutaneous fat area(by CT) ;Blood Lipid ;Adiponectin, hs-CRP, Leptin;change microbiota from stool sample