None listed
Conditions
Interventions
Dietary Supplement : Consumption of placebo or combined extract of Adenophora triphylla var. japonica Hara , twice a day for 12 weeks ( 750mg/day)
Sponsors
Dong Il Pharmtec
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Subject who voluntarily agree to participate and signs informed consent form 2) 20 years= Age = 60years) 3) 25kg/m^2= BMI =29.9kg/m^2
Exclusion criteria
Exclusion criteria: 1) Subjects with severe cerebrovascular disease, cardiac disease (If that patient's clinical status is stable, they can participate in the clinical trial according to investgator) within recent 6 months 2) Subjects for uncontrolled hypertension(systolicBP = 160 mmHg or diastolicBP = 100 mmHg) 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) Subjects with TSH(thyroid-stimulating hormone) = 0.1 uIU/ml or = 15 uIU/ml 5) Subjects with Creatinine = 2 times the upper limit of normal 6) Subjects with AST or ALP = 3 times the upper limit of normal 7) Subjects with complaint of severe gastrointestinal symptoms such as heartburn, dyspepsia 8) Subjects who take the medicine that can affect the state of weight change (uptake inhibitors, appetite suppressant, health functional food for diet, antidepressants, ß- blocker, diuretics, contraceptives, steroid, and female sex hormone) within recent 1 months 9) Participation in commercial diet program within the 3 months prior to screening 10) Participation in any clinical trial within the 1 month prior to screening or have a plan to participate in other clinical trial 11) Subjects who get hospitalization, medications or rehabilitation treatments for Alcohol disorders, cardiovascular disease, disorder of central nervous system 12) Subjects with the musculoskeletal disorders or restricted physical activity 13) Women who are pregnant of lactating or planning to pregnant 14) Subjects which in the opinion investigator could affect preclude evaluation of response
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chainge in fat percentage(by Dual Energy X-Ray Absorptiometry, DEXA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Brachial circumference, Femoral circumference, 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);Basal metabolism rate;Blood Lipid ;hs-CRP, Adiponectin, Leptin;Body weight | — |
Countries
Korea, Republic of
Contacts
Public ContactJUNG SOOK
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed