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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name