A 4 week, open label clinical trial for the evaluation of the efficacy and safety of S-light program on reducing body weight and body fat of overweight females.
- Conditions
- Not Applicable
- Registration Number
- KCT0000932
- Lead Sponsor
- AmorePacific
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 50
1) Female subjects between 20-65years of age inclusive.
2) BMI of 26.0-29.9kg/m2
3) Evidense of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
1. Subjects with systolic BP 160> or diastolic BP 100>mmHg
2. Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose 126= or random blood glucose =200
3. Subjects with severe cerebrovascular disease(infarct, hemorrage), cardiac disease(angina, myocardiac infarct, heart failure, arrhythmias that require treatment) within recent 6 months. (If that patient's clinical status is stable, they can participate in the clinical trial according to the investgator)
4.Subjects with gastrointestinal hemorrhage according to clinical examination of the investgator.
5. Subjets with a history of cancer and inetrvention within the 5 years prior to screening.
6. Use of prescription drugs or supplements known to alter body weight or appetite, antidepressants, oral contraceptive, steroid, female sex hormon within the 1 months prior to screenin.
7. Participation in any diet program within the 3 months prior to screening.
8. Subjects with endocrinopathy or abnormal screening TSH value(=0.1uU/ml or =10uU/ml)
9. Serum creatinine = 2times the the upper limit of normal
10. Serum AST/ALT = 2times the the upper limit of normal
11. Subjects with a history of CNS disorder(depressivedisorder,schizophrenia, alcoholism, drug addiction )
12. Subjects with the musculoskeletal system disorder or restricted physical activity
13. Woman who are pregnant or lactating.
14. Subjects with in the soybean allergy.
15. Subjects which in the opinion investigator could affect preclude evauation of response.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method