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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001611

Enrollment

Registered

2015-09-02

Start date

2015-08-19

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 were randomly allocated to placebo group or yellow yeast rice group. Then subjects consume palcebo or yellow yeast rice (monacolin K) powder twice a day, each time 1 pouc

Eligibility

Sex/Gender

All

Inclusion 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

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 5) Women receiving hormone therapy 6) Chronic smoker (= 20 cigarettes / day) 7) Alcoholic subjects or subjects who consume of alcohol more than 140g per week (example: soju about 2.5 bottles/week, about 2.5 glasses/day) 8) Excessive exercise (= 10 hours / week) 9) Participation in other human study within 4 weeks before the first visit 10) Subjects sensitive to test materials 11) Any condition that the principal investigator believes may put the subjects at undue risk

Design outcomes

Primary

Measure	Time frame
Blood lipid profiles	—

Secondary

Measure	Time frame
Markers of blood circulation	—

Countries

Korea, Republic of

Contacts

Public ContactYoungsook Ahn

Ewha Womans University

verdancys@naver.com+82-2-3277-3087

Outcome results