UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013663 |
|---|---|
| Receipt number | R000015376 |
| 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 |
| Date of disclosure of the study information | 2014/04/08 |
| Last modified on | 2020/10/12 12:12:40 |
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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
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
a-nohara@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015376
