None listed
Conditions
Interventions
Dietary Supplement : Subjects will be randomly assigned to receive ratoferrin 300mg or placebo.
Subjets will orally self-adminster ratoferrin 300mg or placebo qd, for 12weeks.
Sponsors
Lion Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and 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.
Exclusion criteria
Exclusion criteria: 1. Subjects with systolic BP 160> or diastolic BP 100>mmHg or use of beta blocker or hydragogue 2. Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose 126= or random blood glucose =200 3. Subjects with endocrinopathy or abnormal screening TSH value(=0.1uU/ml or =10uU/ml) 4. Serum AST/ALT = 3times the the upper limit of normal 5. Serum creatinine = 2times the the upper limit of normal 6. Use of prescription drugs or supplements known to alter body weight or appetite, antidepressants, oral contraceptive, steroid, female sex hormon. 7. Subjets with clinically significant cardiovascular disease within the 6months prior to screening 8. Subjets with a history of cancer and inetrvention within the 5 years prior to screening. 9. Subjects with a history of CNS disorder(depressivedisorder,schizophrenia, alcoholism, drug addiction ) 10. Women of childbearing age who are disagreed with effective contraceptions in the clinical trial period 11. Woman who are pregnant or lactating. 12. Participation in any clinical trial within the 3 months prior to screening. 13.Subjects with bleeding risk factor of stomach 14.Subjects with the musculoskeletal system disorder or restricted physical activity 15. Subjects which in the opinion investigator could affect preclude evauation of response. 16. subjects with cow milk allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight;Chainge in fat percentage(by DEXA) ;Chainge in fat mass(by DEXA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in veceral fat(by CT);Change in subcutaneous fat(by CT);Change in waist circumference | — |
Countries
Korea, Republic of
Contacts
Public ContactYangim Hur
Inje University Seoul Paik Hospital
Outcome results
None listed