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The randomized controlled clinical trial of the utilization of Red Koji (Red Mold Rice) in dietary therapy for serum lipid improvement

The randomized controlled clinical trial of the utilization of Red Koji (Red Mold Rice) in dietary therapy for serum lipid improvement - The randomized controlled clinical trial of the utilization of Red Koji (Red Mold Rice) in dietary therapy for serum lipid improvement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007694
Enrollment
32
Registered
2012-04-09
Start date
2012-05-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Hyperlipemia

Interventions

Dietary therapy + Red Koji Dietary therapy

Sponsors

Graduate School of Medicine, Chiba University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)People with LDL-cholesterol level of 140 and over mg/dL without the past of a coronary artery disease 2)patients under an enforcement schedule or enforcement of dietary therapy for hypercholesterolemia 3)Age >=20 years, <80 years (Male and Female) 4)A consent form for participating in this study is submitted

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Change of LDL-C from the baseline to 4 and 8 weeks later

Countries

Japan

Contacts

Public ContactKazuki Kobayashi

Graduate School of Medicine, Chiba University Clinical Cell Biology and Medicine

koba-chi@faculty.chiba-u.jp043-226-2092

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026