UMIN-CTR Clinical Trial

Basic information
Public title	Effect of cereal breakfast on secondary prevention in the patients with ischemic heart disease and with arteriosclerosis
Acronym	cereal food for anti-arteriosclerosis
Scientific Title	Effect of cereal breakfast on secondary prevention in the patients with ischemic heart disease and with arteriosclerosis
Scientific Title:Acronym	the benefit of cereal food for anti-arteriosclerosis
Region	Japan

Condition
Condition	Patients who underwent coronary artery bypass surgery due to ischemic heart disease or patients who have risk factor(s) for arteriosclerosis
Classification by specialty	Cardiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Secondary prevention for ischemic heart disease due to antihypertensive effect or improve of dyslipidemia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood pressure
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Take 50 gram of cereal breakfast for breakfast
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with stable condition after the surgery or patients who have risk factor(s) for arteriosclerosis
Key exclusion criteria	malignant tumor GNRI<90 allergy for the food
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Matsushita
Organization	Juntendo University
Division name	Department of cardiovascular surgery
Zip code	113-8421
Address	2-1-1, Hongo, Bunkyo-ku Tokyo Japan
TEL	03-3813-3111
Email	saty-m@juntendo.ac.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Matsushita
Organization	Juntendo University
Division name	Department of cardiovascular surgery
Zip code	113-8421
Address	2-1-1, Hongo, Bunkyo-ku Tokyo Japan
TEL	03-3813-3111
Homepage URL
Email	saty-m@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Calbee corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Juntendo University
Address	2-1-1, Hongo, Bunkyo-ku Tokyo Japan
Tel	03-3813-3111
Email	saty-m@juntendo.ac.jp

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	順天堂医院（東京都）、緑十字クリニック（神奈川県）

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 01 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	Enrolling by invitation
Date of protocol fixation	2018 Year 11 Month 26 Day
Date of IRB	2018 Year 11 Month 26 Day
Anticipated trial start date	2018 Year 12 Month 03 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 27 Day
Last modified on	2021 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039934