None listed
Conditions
Interventions
Dietary Supplement : Subjects will be randomized to receive DW2010 1000mg, DW2010 100mg or placebo. Subjects will orally self-adminster DW2010(1), DW2010 1000mg, DW2010 100mg or placebo 1 pouch per da
Sponsors
Dongwha Pharmaceutical
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chainge in fat percentage(by Dual Energy X-Ray Absorptiometry, DEXA) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactJae Heon Kang
Inje University Seoul Paik Hospital
Outcome results
None listed