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Clinical Trials/KCT0001611
KCT0001611
Completed
未知

Human study for investigating the effectiveness and safety of yellow yeast rice on control of blood cholesterol

Ewha Womans University0 sites68 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Endocrine, nutritional and metabolic disease
Sponsor
Ewha Womans University
Enrollment
68
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional Study
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\) Subject who voluntarily agrees to participate and sign in informed consent form
  • 2\) Man and postmenopausal women (45 years \= Age )
  • 3\) 18 \= BMI (Body Mass Index) \= 30 kg/m2
  • 4\) Fasting LDL\-cholesterol level \= 130mg/dL
  • 5\) Fasting triglyceride level\< 300mg/dL

Exclusion Criteria

  • 1\) Subjects who consistently consumed the drugs related to lipid metabolism (lipid\-lowering drug, antihypertensive drug, weight\-loss drug etc. examples: statin, fibrate, diuretics, ezetimibe, beta blocker, blocking agent and acetylsalicylic acid, bile acid\-binding resins) or inflammation metabolism within 4 weeks before the first visit
  • 2\) Subjects who consumed the functional food (lipid metabolism or inflammation) or food (plantsterol, w\-3 fatty acid, aloe, chitosan, extract of onion etc.) within 4 weeks before the first visit
  • 3\) Subjects who controlling body weight or subjects who have changed of body weight more than 10% within 6 month before the first visit
  • 4\) Following diseases :
  • \- Subjects who had a diagnosis of myocardial infarction, stroke, hypertension
  • \- Diabetes or subjects who fasting glucose level \= 126mg/dL at screening
  • \- Liver dysfunction (AST, ALT \= 2\.5 X upper limit of normal range)
  • \- Renal dysfunction (serum creatinine \= 1\.4mg/dL)
  • \- Chronic inflammatory bowel disease
  • \- Autoimmune disease, hyperthyroidism, hypothyroidism or malignant tumor

Outcomes

Primary Outcomes

Not specified

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