UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038814 |
|---|---|
| Receipt number | R000044254 |
| Scientific Title | Effect of nutritional food intake on body composition after anterior cruciate ligament reconstruction |
| Date of disclosure of the study information | 2019/12/09 |
| Last modified on | 2021/12/21 09:08:54 |
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Basic information
Public title
Effects of nutritional food intake after knee ligament reconstruction
Acronym
Knee ligament surgery and nutritional food
Scientific Title
Effect of nutritional food intake on body composition after anterior cruciate ligament reconstruction
Scientific Title:Acronym
Changes in body composition after anterior cruciate ligament reconstruction
Region
| Japan |
Condition
Condition
Anterior cruciate ligament injury
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to understand in detail the effects of ingesting nutritional foods on body composition for patients after anterior cruciate ligament reconstruction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle mass 3 weeks after surgery
Key secondary outcomes
Body weight, body fat mass, lean mass, body fat percentage, BMI, basal metabolic rate at 3 weeks after surgery
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of nutritional food (collagen aid (Salaya Co., Ltd.) 12.5g) 3 times a day for 3 weeks after surgery
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with anterior cruciate ligament injury based on clinical symptoms and imaging findings
Key exclusion criteria
Patients judged by doctors as inappropriate for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Sports Medical Science
Zip code
5650871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6210-8442
tanahiro-osk@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Sports Medical Science
Zip code
5650871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6210-8442
Homepage URL
tanahiro-osk@umin.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Saraya. Co. Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Prefecture University
Seifu Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2, Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8296
handai-nintei@hp-crc.med.osaka-u.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
大阪大学医学部附属病院（大阪府）、正風病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 09 | 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
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 12 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 06 | Day |
Last modified on
| 2021 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044254
