UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028715
Receipt No. R000032834
Scientific Title Effects of protein and medium-chain triglycerides-enriched milk on rehabilitation outcomes in malnourished older patients with hip fracture: a randomized controlled trial.
Date of disclosure of the study information 2017/08/28
Last modified on 2018/08/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of protein and medium-chain triglycerides-enriched milk on rehabilitation outcomes in malnourished older patients with hip fracture: a randomized controlled trial.
Acronym Protein, medium-chain and -rehabilitation outcomes.
Scientific Title Effects of protein and medium-chain triglycerides-enriched milk on rehabilitation outcomes in malnourished older patients with hip fracture: a randomized controlled trial.
Scientific Title:Acronym Protein, medium-chain and -rehabilitation outcomes.
Region
Japan

Condition
Condition Hip fracture
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of protein and medium-chain triglycerides-enriched milk on rehabilitation outcomes in malnourished older patients with hip fracture.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes FIM

Compare between pre-treatment and 8 weeks after treatment
Key secondary outcomes 1, Muscle strength (hand grip)
2, Skeletal muscle mass(Calf circumference)
3, Walking speed
4,Nutritional status
5, Cognitive function(FAST)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 1,Protein and medium-chain triglycerides-enriched milk. 200ml
Branched chain amino acid:BCAA 2830mg
medium-chain triglycerides:MCT 6.3g
2, Rehabilitation
Interventions/Control_2 1, Rehabilitation
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1,Hip fracture patients aged 65 or older
2,Under appropriate nutrition management
3,Patients who could walk with or without using a walking aid before hip fracture
4,Evaluated as malnutrition or at risk
Key exclusion criteria 1,Load limitation on an affected lower limb
2,Patients who have neurological findings such as lower limb paralysis
3,Patients who needed acute treatment with complication
4,Patients who are iudged unable to walk by physication
5,patients who are iudged inappropriate for the study by physication
6,Severe renal dysfunction
7,Cognitive decline
8,Severe dysphagia
9,Lower extremity edema
10,Lactose intolerance
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiko Nagaoka
Organization Sunrise Sakai Hospital
Division name Nursing department
Zip code
Address 3156-1 Hiji, Hayami, Oita 879-1506
TEL 09777222266
Email usrknjsnsi@gmal.com

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuo Kobayashi
Organization Sunrise Sakai Hospital
Division name Committee of Research, Education and Training
Zip code
Address 3156-1 Hiji, Hayami, Oita 879-1506
TEL 09777222266
Homepage URL
Email rinri@heiseikai.com

Sponsor
Institute Sunrise Sakai Hospital
Institute
Department

Funding Source
Organization Sunrise Sakai Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kumamoto Rehabilitation Hospital Department of Rehabilitation
Yoshihiro Yoshimura
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 28 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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 18 Day
Last modified on
2018 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032834

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.