KCT0001040
Completed
未知
The clinical pilot study for the evaluation of the efficacy and safety of Monascus-fermentation (Monascus-fermented black bean) on reducing body weight and serum total cholesterol obese subjects
Inje University Seoul Paik Hospital0 sites30 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Inje University Seoul Paik Hospital
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Male and female subjects between 20\-65years of age inclusive.
- •2\) BMI of 25\.0\-29\.9kg/m2
- •3\) Serum total cholesterol \= 240mg/dl
- •4\) 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
- •1\. Subjects with systolicBP \= 160 mmHg or diastolicBP \= 100 mmHg and also taking a beta blocker or a hydragogue.
- •2\. Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose \= 126 mg/dL or random blood glucose \= 200 mg/dL.
- •3\. Subjects who taking anti\-hypercholesterolemia
- •4\. Subjects with endocrinopathy or abnormal screening TSH value(\=0\.1uU/ml or \=10 uU/ml).
- •5\. Serum AST/ALT \= 3 times the upper limit of normal.
- •6\. Serum creatinine \= 2 times the upper limit of normal.
- •7\. Use of prescription drugs or supplements known to alter body weight or appetite, antidepressants, oral contraceptive, steroid, female sex hormon.
- •8\. Subjects with clinically significant cardiovascular disease within the 6 months prior to screening.
- •9\. Subjects with a history of cancer and intervention within the 5 years prior to screening.
- •10\. Subjects with a history of CNS disorder(depressive disorder, schizophrenia, alcoholism, drug addiction).
Outcomes
Primary Outcomes
Not specified
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