UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044069 |
|---|---|
| Receipt number | 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 | 2024/02/06 22:11:19 |
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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
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
fukao777@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Cardiovascular Biology and Medicine
Institute
Department
Personal name
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
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
https://doi.org/10.14789/jmj.JMJ23-0008-OA
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.14789/jmj.JMJ23-0008-OA
Number of participants that the trial has enrolled
14
Results
The rate of change in lean body mass was significantly higher in the intervention group compared to the control group. The rate of change in plasma leucine concentration and that in lean body mass was positively correlated only in the intervention group, and the rate of change in plasma leucine concentration was also positively correlated with the rate of change in grip strength.
Results date posted
| 2024 | Year | 02 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 12 | Month | 22 | Day |
Baseline Characteristics
Nutritional guidance, focused on leucine (intervention group) or general nutritional guidance (control group), was provided for six months to patients participating in cardiac rehabilitation.
Participant flow
Adverse events
none
Outcome measures
Body composition, grip strength, hematological test results, and diet
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
Registration is being processed.
Management information
Registered date
| 2021 | Year | 04 | Month | 28 | Day |
Last modified on
| 2024 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049597
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| Registered date | File name |
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