KCT0000840
Recruiting
N/A
The clinical study for the evaluation of the efficacy and safety of Monascus-fermentation (Monascus-fermented black bean) on reducing body weight of overweight or obese subjects
Inje University Seoul Paik Hospital0 sites60 target enrollmentTBD
ConditionsNot Applicable
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not Applicable
- Sponsor
- Inje University Seoul Paik Hospital
- Enrollment
- 60
- Status
- Recruiting
- 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\) 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 with endocrinopathy or abnormal screening TSH value(\=0\.1uU/ml or \=10 uU/ml).
- •4\. Serum AST/ALT \= 3 times the upper limit of normal.
- •5\. Serum creatinine \= 2 times 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\. Subjects with clinically significant cardiovascular disease within the 6 months prior to screening.
- •8\. Subjects with a history of cancer and intervention within the 5 years prior to screening.
- •9\. Subjects with a history of CNS disorder(depressive disorder, schizophrenia, alcoholism, drug addiction).
- •10\. Woman who are pregnant or lactating or women of childbearing age who are disagreed with effective contraceptions in the clinical trial period.
Outcomes
Primary Outcomes
Not specified
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