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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001040

Enrollment

Registered

2014-04-07

Start date

2012-12-12

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Subjects will be randomized to receive Monascus-fermentation (Monascus-fermented black bean) 2.5g, 5.0g or placebo. Subjects will orally self-adminster Monascus-fermentation (Mona

Eligibility

Sex/Gender

All

Inclusion 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

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). 11. Women of childbearing age who are disagreed with effective contraceptions in the clinical trial period. 12. Woman who are pregnant or lactating. 13. Participation in any clinical trial within the 3 months prior to screening. 14. Subjects who change weight over 10 percent within 3 months 15. Subjects with the musculoskeletal disorders or restricted physical activity. 16. Subjects who could affect preclude evaluation of response in the opinion investigator.

Design outcomes

Primary

Measure	Time frame
Body weight ;Fat percentage(by DEXA) ;Fat mass(by DEXA) ;Serum total cholesterol	—

Secondary

Measure	Time frame
Waist circumference	—

Countries

Korea, Republic of

Contacts

Public ContactMiyoung Lee

Inje University Seoul Paik Hospital

Outcome results