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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044069
Receipt No. R000049597
Scientific Title Effect to the health condition by the nutrition guidance in consideration of the amino acid levels in phase 3 cardiac rehabilitation
Date of disclosure of the study information 2021/05/01
Last modified on 2021/04/28

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Basic information
Public title Effect to the health condition by the nutrition guidance in consideration of the amino acid levels in phase 3 cardiac rehabilitation - randomised controlled trial -
Acronym nutrition study in consideration of the amino acid levels in phase 3 cardiac rehabilitation
Scientific Title Effect to the health condition by the nutrition guidance in consideration of the amino acid levels in phase 3 cardiac rehabilitation
Scientific Title:Acronym Effect to the health condition by the nutrition guidance in consideration of the amino acid levels in phase 3 cardiac rehabilitation - randomised controlled trial -
Region
Japan

Condition
Condition cardiovascular disease
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine effect on cardiac rehabilitation by the nutrition education in consideration of an amino acid level and an effect to healthy quality of life.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Readmission for the cardiovascular diseases one year after the nutrition education initiation
Key secondary outcomes Anaerobic threshold
healthy QOL

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food Behavior,custom
Interventions/Control_1 nutrition education/one year
Interventions/Control_2 Normal treatment
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 of phase 3 cardiac rehabilitation
Key exclusion criteria 1.Chronic kidney disease on hemodialysis, severe liver disease.
2.The person who takes an amino acid-based supplement
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Miho
Middle name
Last name Yokoyama
Organization Juntendo University
Division name Cardiovascular Biology and Medicine
Zip code 113-8421
Address 2-1-1, Hongo, Bunkyo-ku
TEL +81338133111
Email mipocch@juntendo.ac.jp

Public contact
Name of contact person
1st name Kosuke
Middle name
Last name Fukao
Organization Juntendo University
Division name Cardiovascular Biology and Medicine
Zip code 1130033
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL +81338133111
Homepage URL
Email fukao777@juntendo.ac.jp

Sponsor
Institute Juntendo University
Cardiovascular Biology and Medicine
Institute
Department

Funding Source
Organization Juntendo University
Faculty of Health and Sports Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Juntendo University
Address 2-1-1
Tel +81338133111
Email fukao777@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 順天堂大学附属順天堂医院

Other administrative information
Date of disclosure of the study information
2021 Year 05 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 Open public recruiting
Date of protocol fixation
2020 Year 07 Month 28 Day
Date of IRB
2020 Year 07 Month 30 Day
Anticipated trial start date
2021 Year 02 Month 20 Day
Last follow-up date
2023 Year 03 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
2021 Year 04 Month 28 Day
Last modified on
2021 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049597

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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