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 UMIN000019360
Receipt No. R000022389
Scientific Title A single-blind, placebo controlled, randomized trial to evaluate the efficacy of protein fortified food in rehabilitation patients.
Date of disclosure of the study information 2015/10/20
Last modified on 2020/04/22

* 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 A single-blind, placebo controlled, randomized trial to evaluate the efficacy of protein fortified food in rehabilitation patients.
Acronym A single-blind, placebo controlled, randomized trial to evaluate the efficacy of protein fortified food in rehabilitation patients.
Scientific Title A single-blind, placebo controlled, randomized trial to evaluate the efficacy of protein fortified food in rehabilitation patients.
Scientific Title:Acronym A single-blind, placebo controlled, randomized trial to evaluate the efficacy of protein fortified food in rehabilitation patients.
Region
Japan

Condition
Condition Patients in recovery phase rehabilitation hospital
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of protein fortified food on the maintenance or hypertrophy of skeketal muscle mass in hospitalized patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Skeletal muscle mass (BIA, thigh muscle area by Computed tomography) after 16 weeks intervention
Key secondary outcomes Muscle strength (handgrip, lower limb), ADL (FIM, mBI), Physical activity (walking test, timed up & go test, chair-stand test), Nutritional index(alb, pre-Alb, IGF-1, DHEA-s, free-teststerone, 25(OH)D, PTH, Ca), length of hospital stay, discharge disposition (home/not home)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Protein(10g/pack) and Vitamin D(20ug/pack) fortified food (2pack/day, 16weeks)
Interventions/Control_2 Placebo(Protein 0g, Vitamin D 0ug) food (2pack/day, 16weeks)
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Aged 40 or older
2. FIM locomotion subscore is 4 or less, social interaction subscore is 6 or over and comprehension and expression is 5 or over
3. Within two weeks after admission
4. Patients who can ride normal wheelchair
Key exclusion criteria 1. Impossible to get informed concent by cognitive deficit
2. Impossible to be treated with exercise therapy due to complication or previous disease
3. Impossible to swallow experimental food
4. Patients who receive parenteral or enteral Nutrition
5.eGFR score is less than 60 mL/min/1.73m2
6. peel of citrus species supplementation
7. Vitamin D supplementation or medicine
8. Protein or amino acid supplementation
9. Patients who are judged inappropriate for the study by the physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kunitsugu
Middle name
Last name Kondo
Organization Tokyo Bay Rehabilitation Hospital
Division name Tokyo Bay Rehabilitation Hospital
Zip code 275-0026
Address 4-1-1 Yatsu, Narashino-shi, Chiba
TEL 047-453-9000
Email k.kondo@wanreha.net

Public contact
Name of contact person
1st name Kaoru
Middle name
Last name Honaga
Organization Tokyo Bay Rehabilitation Hospital
Division name Rehabilitation Department
Zip code 275-0026
Address 4-1-1 Yatsu, Narashino-shi, Chiba
TEL 047-453-9000
Homepage URL
Email rh_fortune@hotmail.com

Sponsor
Institute Tokyo Bay Rehabilitation Hospital
Institute
Department

Funding Source
Organization Morinaga Milk Industry Co, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Tokyo Bay Rehabilitation Hospital
Address 4-1-1 Yatsu, Narashino-shi, Chiba
Tel 047-453-9000
Email shinsakai@wanreha.net

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 東京湾岸リハビリテーション病院

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 20 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
2015 Year 09 Month 01 Day
Date of IRB
2015 Year 09 Month 30 Day
Anticipated trial start date
2015 Year 10 Month 20 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2020 Year 05 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 15 Day
Last modified on
2020 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022389

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.