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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038814
Receipt No. 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 2019/12/06

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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
Email 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
Email tanahiro-osk@umin.ac.jp

Sponsor
Institute Osaka University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 06 Day
Date of IRB
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

Other
Other related information

Management information
Registered date
2019 Year 12 Month 06 Day
Last modified on
2019 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044254

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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