UMIN-CTR Clinical Trial

Basic information
Public title	The randomized controlled crossover clinical trial of Red Koji (Red Mold Rice) in the serum lipid-improvement with dietary therapy for prevention of atherosclerosis
Acronym	The randomized controlled crossover clinical trial of Red Koji (Red Mold Rice) with dietary therapy
Scientific Title	The randomized controlled crossover clinical trial of Red Koji (Red Mold Rice) in the serum lipid-improvement with dietary therapy for prevention of atherosclerosis
Scientific Title:Acronym	The randomized controlled crossover clinical trial of Red Koji (Red Mold Rice) with dietary therapy
Region	Japan

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

Objectives
Narrative objectives1	Examine the serum lipid improving effect as well as safety of proper use of Red Koji as a dietary supplement under control of medical management.
Basic objectives2	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 with Red Koji
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Dietary therapy+Red Koji ->(washout period) -> Dietary therapy
Interventions/Control_2	Dietary therapy -> (washout period) -> Dietary therapy+Red Koji
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	16

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroshi Mabuchi
Organization	Kanazawa University Graduate School of Medical Sciences
Division name	Department of Lipidology
Zip code
Address	13-1 Takaramachi, Knazawa, 920-8640
TEL	076-265-2000
Email	mabuchi@med.kanazawa-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Atsushi Nohara
Organization	Kanazawa University Graduate School of Medical Sciences
Division name	Department of Lipidology
Zip code
Address	13-1 Takaramachi, Knazawa, 920-8640
TEL	076-265-2000
Homepage URL
Email	a-nohara@med.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	Kanazawa University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2014 Year 04 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 02 Month 25 Day
Date of IRB	2014 Year 03 Month 27 Day
Anticipated trial start date	2014 Year 04 Month 17 Day
Last follow-up date	2015 Year 10 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 04 Month 07 Day
Last modified on	2020 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015376