UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048855 |
|---|---|
| Receipt number | R000055508 |
| Scientific Title | The impact of high-protein confectionery on patients with low nutrition A single-center prospective observational study |
| Date of disclosure of the study information | 2022/09/10 |
| Last modified on | 2023/03/06 13:25:46 |
* 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
The impact of high-protein confectionery on patients with low nutrition
A single-center prospective observational study
Acronym
The impact of high-protein confectionery on patients with low nutrition
A single-center prospective observational study
Scientific Title
The impact of high-protein confectionery on patients with low nutrition
A single-center prospective observational study
Scientific Title:Acronym
The impact of high-protein confectionery on patients with low nutrition
A single-center prospective observational study
Region
| Japan |
Condition
Condition
Stroke, Femur Fracture, Vertebral Compression Fracture, Disuse syndrome
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the effects of high protein confectionery on nutritional status and rehabilitation assessment in patients with low nutritional status admitted to a recovery rehabilitation ward.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent change in percentage of caloric intake relative to required caloric intake at admission and discharge.
Key secondary outcomes
Functional Independence Measure
Grip strength
Isometric knee extension muscle strength
Skeletal muscle index
Nutritional status (Mini Nutritional Assessment, weight, pre-albumin, and other blood tests)
Geriatric Nutritional Risk Index
Functional Oral Intake Scale
Food Form
oral nutritional supplements Satisfaction (self-rated 10-point scale)
Charlson Comorbidity Index
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
During the hospitalization, in addition to normal hospitalization, the patient is allowed to freely consume high protein confectionery.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stroke patients, femur fracture patients, vertebral compression fracture patients, and disuse syndrome patients were determined to be undernourished by Mini Nutritional Assessment-Short Form (MNA-SF).
Key exclusion criteria
(1) Patients with oral nutritional difficulties
(2) Patients with implanted pacemakers
(3) Patients with dementia or psychiatric disorders that make evaluation difficult.
(4) Patients with renal dysfunction or other diseases that make evaluation inappropriate (eGFR 44 or less)
(5)patients with prolonged difficulty in standing and walking due to unstable fracture or pain
(6). diabetic patients (HbA1c: NGSP 6.5 or higher)
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Kamajiri |
Organization
Kishiwada Rehabilitation Hospital
Division name
Rehabilitation Center
Zip code
596-0827
Address
2-8-10 Kamimatu-cho, Kishiwada, Osaka
TEL
072-426-7777
n_kamajiri@eishinkaihsp.or.jp
Public contact
Name of contact person
| 1st name | Noboru |
| Middle name | |
| Last name | Kamajiri |
Organization
Kishiwada Rehabilitation Hospital
Division name
Rehabilitation Center
Zip code
596-0827
Address
2-8-10 Kamimatu-cho, Kishiwada, Osaka
TEL
072-426-7777
Homepage URL
n_kamajiri@eishinkaihsp.or.jp
Sponsor or person
Institute
Kishiwada Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kishiwada Rehabilitation Hospital
Address
2-8-10 Kamimatu-cho, Kishiwada, Osaka
Tel
072-426-7777
t_fuchigami@eishinkaihsp.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 10 | 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 | 09 | Month | 05 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055508
