UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048802 |
|---|---|
| Receipt number | R000055346 |
| Scientific Title | Effect of Soybean Peptide-Containing Beverage on Muscle Mass and Muscle Quality in Patients Admitted to Kaifukuki Rehabilitation Ward Historical control study |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2024/12/09 15:38:54 |
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Basic information
Public title
Effect of Soybean Peptide-Containing Beverage on Muscle Mass and Muscle Quality in Patients Admitted to Kaifukuki Rehabilitation Ward Historical control study
Acronym
Effect of Soybean Peptide-Containing Beverage on Muscle Mass and Muscle Quality in Patients Admitted to Kaifukuki Rehabilitation Ward Historical control study
Scientific Title
Effect of Soybean Peptide-Containing Beverage on Muscle Mass and Muscle Quality in Patients Admitted to Kaifukuki Rehabilitation Ward Historical control study
Scientific Title:Acronym
Effect of Soybean Peptide-Containing Beverage on Muscle Mass and Muscle Quality in Patients Admitted to Kaifukuki Rehabilitation Ward Historical control study
Region
| Japan |
Condition
Condition
cerebrovascular disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of nutritional management (consumption of soy peptide-containing beverages) on muscle mass and muscle quality in patients with cerebrovascular disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition (mainly skeletal muscle and body fat)
Key secondary outcomes
Assessment of Functional Activities of Daily Living, Dementia Independence for Daily Living, Functional Independence Measure (FIM), FIM gain, days in ward, total rehabilitation units, days in hospital after onset, MMSE, Revised version of the Ability for Basic Movement Scale II (ABMS II), grip strength, Borg Balance Scale, lower leg circumference, body weight, BMI, MUST, MNA-SF, GILM, average nutrient intake, protein requirement, average protein intake, energy per body weight, protein per body weight, NPC/N ratio, availability of nutritional supplements presence/absence, oral supplementation, non-protein calorie/nitrogen ratio calculation, sarcopenia diagnosis, blood tests
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Control: Conventional inpatient diet (historical concoction)
Interventions/Control_2
Beverages containing soy peptides 1 pack/day. At least 2 months according to the length of hospitalization.
Interventions/Control_3
Casein-containing beverage 1 pack/day.At least 2 months according to the length of hospitalization.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with cerebrovascular disease who were admitted to the Recovery Rehabilitation Unit of Koyama Rehabilitation Hospital and who agreed to participate in the study
Key exclusion criteria
Patients whose general condition is not stable (deterioration of condition, possible transfer to other hospitals)
Patients with soy allergy
Patients with significant dysphagia (patients for whom ingestion of this product may induce aspiration pneumonia)
Patients with low average nutritional intake (less than 80% of the energy requirement calculated by the Harris-Benedict formula)
Patients who have difficulty consuming research products more than 3 days per week.
Patients with significant edema
Patients with severe renal or cardiac disease or diabetes mellitus (BNP > 200 pg/ml, eGFR < 30, HbA1c > 9.0%, any one of which is persistent)
Patients who are judged to be inappropriate for the subject by the physician's judgment
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Suzuki |
Organization
Jikei University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
105-8471
Address
3-19-18 Nishi-Shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
ss1135071@gmail.com
Public contact
Name of contact person
| 1st name | Etsuko |
| Middle name | |
| Last name | Kurata |
Organization
Koyama Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
417-0801
Address
405-25 Ohbuchi, Fuji City, Shizuoka Prefecture
TEL
0545-36-2000
Homepage URL
eiyouka@momoha.or.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Koyama Rehabilitation Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Koyama Rehabilitation Hospital
Address
405-25 Ohbuchi, Fuji City, Shizuoka Prefecture
Tel
0545-36-2000
eiyouka@momoha.or.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
湖山リハビリテーション病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 01 | 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
| 2022 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 08 | Month | 31 | Day |
Last modified on
| 2024 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055346
