UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019360 |
|---|---|
| Receipt number | 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 | 2022/04/20 18:32:18 |
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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
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
rh_fortune@hotmail.com
Sponsor or person
Institute
Tokyo Bay Rehabilitation Hospital
Institute
Department
Personal name
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
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
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000022389
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000022389
Number of participants that the trial has enrolled
50
Results
The cross sectional areas of fat infiltration muscles in the thigh decreased in the HP group more than pracebo group. Otherwise, there was no difference in the total cross-sectional area of the thigh muscles between two groups.
In the HP group, resting metabolism rate was increased and body fat rate was decreased significantly after intervention.
Blood 25 (OH) D was significantly higher in the HP group after intervention.
Results date posted
| 2020 | Year | 12 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who admitted to the convalescent rehabilitation hospital and met the following 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
Participant flow
Fifty patients were entered in this study. Twenty-five patients were assigned to HP group and placebo group.
Three patients in the HP group dropped out and two in the placebo group dropped out during intervention. Then 22 in the HP group and 23 in the placebo group were included in the analysis.
Adverse events
No adverse events related to the intervention were observed in either group throughout the study.
Outcome measures
Primary outcomes:
Skeletal muscle mass (BIA, thigh muscle area by Computed tomography) after 16 weeks intervention
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)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022389
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/12/23 | HiPro試験実施計画書v11.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/12/23 | Hipro試験データベース.xlsx |
