The randomized controlled crossover clinical trial of Red Koji (Red Mold Rice) in the serum lipid-improvement with dietary therapy for prevention of atherosclerosis
- Conditions
- Dyslipidemia
- Registration Number
- JPRN-UMIN000013663
- Lead Sponsor
- Kanazawa University Graduate School of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 16
Not provided
1)Patients with familial hypercholesterolemia or with LDL-cholesterol level of 180 and over mg/dL 2)People with rice allergy, and people who have resistance in eating rice 3)Patients taking statin drugs within 4 weeks (or Probucol within 8 weeks) in the past 4)Patients with type 1 diabetes or diabetic patients with HbA1c level of over 8% 5)Patients with sever diseases other than diabetes, such as liver disease, a renal disease, and cardiac disease 6)Patients with the past, such as a food allergy, idiosyncrasy, and alcoholism 7)People who participated in other clinical trials within the past three months before the start of this clinical trial, or who have participated in other clinical trials at the start of this clinical trial 8)Patients who are pregnant, breastfeeding or intention to becoming pregnant 9)Patients whose LDL-cholesterol level became less than 140 mg/dL by dietary therapy of period I or patients with TG level of 400 and over mg/dL 10)Patients judged unsuitable by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of LDL-C from the baseline to 4 and 8 weeks with Red Koji
- Secondary Outcome Measures
Name Time Method