A week, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Lactoferrin(enter-coated bovine lactoferrin) 300mg on reducing body weight and body fat of overweight subjects

ion Corporation0 个研究点目标入组 76 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•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.

•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.

发起方

ion Corporation