UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The randomized controlled clinical trial of the utilization of Red Koji (Red Mold Rice) in dietary therapy for serum lipid improvement
Title of the study (Brief title)	The randomized controlled clinical trial of the utilization of Red Koji (Red Mold Rice) in dietary therapy for serum lipid improvement
Region	Japan

Condition
Condition	Hyperlipemia
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examine the usefulness of Red Koji as a dietary supplement in the primary care stage of improvement of life style including dietary therapy in the clinical practice for people with hyperlipidemia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of LDL-C from the baseline to 4 and 8 weeks later
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Dietary therapy + Red Koji
Interventions/Control_2	Dietary therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key 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
Key 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
Target sample size	32

Research contact person
Name of lead principal investigator	Koutaro Yokote
Organization	Graduate School of Medicine, Chiba University
Division name	Clinical Cell Biology and Medicine
Address	1-8-1 Inohana, Chuo-ku, 260-8670, Chiba-city
TEL	043-226-2092
Email	kyokote@faculty.chiba-u.jp

Public contact
Name of contact person	Kazuki Kobayashi
Organization	Graduate School of Medicine, Chiba University
Division name	Clinical Cell Biology and Medicine
Address	1-8-1 Inohana, Chuo-ku, 260-8670, Chiba-city
TEL	043-226-2092
Homepage URL
Email	koba-chi@faculty.chiba-u.jp

Sponsor
Institute	Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Biopharm Research Laboratories Inc.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 19 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2016 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 04 Month 08 Day
Last modified on	2017 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009074