UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037312 |
|---|---|
| Receipt number | R000042524 |
| Scientific Title | Prospective observational study on association of dietary protein intake with changes in muscle strength and skeletal muscle mass, in elderly chronic kidney disease (CKD) patients |
| Date of disclosure of the study information | 2019/07/09 |
| Last modified on | 2025/01/29 10:24:52 |
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Basic information
Public title
Relationship between protein intake and muscle strength and muscle mass in elderly chronic kidney disease patients
Acronym
Relationship between protein intake and muscle strength and muscle mass in elderly chronic kidney disease patients
Scientific Title
Prospective observational study on association of dietary protein intake with changes in muscle strength and skeletal muscle mass, in elderly chronic kidney disease (CKD) patients
Scientific Title:Acronym
Prospective observational study on association of dietary protein intake with changes in muscle strength and skeletal muscle mass, in elderly chronic kidney disease (CKD) patients
Region
| Japan |
Condition
Condition
Elderly nondialysis chronic kidney disease patients (stage3b-4)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the association between dietary protein intake and change of muscle strength and skeletal muscle mass in elderly nondialysis CKD patients, eventually to propose optimal protein intake in elderly CKD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To clarify the association between dietary protein intake and percent change in baseline muscle strength and skeletal muscle mass over two years, in elderly CKD patients.
Key secondary outcomes
To clarify the association between dietary protein intake and factors affecting muscle mass and muscle strength (serum amino acid concentration, acid-base balance, serum vitamin D concentration)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
CKD patients who had been treated in Tokyo Medical College Hachioji Medical Center at least of 6 months before enrolment, and who had been optimized blood pressure and serum electrolyte, and who reserved life instruction including exercise.
Patients who received explanation for purpose and contents of this study, and who agreed by free will.
Patients who can go to hospital for two years.
Key exclusion criteria
Patients who are instructed to rest.
Patients with serious circulatory and respiratory disease.
Patients who are treating musculoskeletal disease.
Patients who have asymmetric lower limbs atrophy.
Patients who require walking aids when moving due to motor failure.
Patients whose body protein catabolism has been renewed by steroid therapy, burns, etc.
Patients with chronic inflammatory disease.
Diabetic patients with HbA1c 7.0 % or higher.
Patients with proteinuria 3.5g/day or higher
Patients with cardiac pacemaker
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Yoshikawa |
Organization
Tokyo Medical College Hachiouji medical Center
Division name
Department of Nephrology and Blood Purification, Kidney Disease Center
Zip code
193-0998
Address
1163 Tatemachi, Hachioji, Tokyo, Japan
TEL
042-665-5611
ionori@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Yoshikawa |
Organization
Tokyo Medical College Hachiouji medical Center
Division name
Department of Nephrology and Blood Purification, Kidney Disease Center
Zip code
193-0998
Address
1163 Tatemachi, Hachioji, Tokyo, Japan
TEL
042-665-5611
Homepage URL
ionori@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical College
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical College
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
Tokyo Midical College research promotion center
Address
6-7-1 Nishishinjyuku Shinjyukuku Tokyo
Tel
03-3343-6211
IRB@tokyo-med.ac.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
東京医科大学八王子医療センター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 09 | 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
65
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Data collection has not finished
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measurement item
Protein intake is calculated by urine storage.
The Amount of energy intake, animal protein and vegetable protein are estimated by the food frequency questionnaire.
Muscle strength is measured by the following items
Grip strength
Isometric knee extension force with a hand-held dynamometer
Skeletal muscle mass is measured by the bioelectrical impedance analysis, and skeletal muscle index (SMI)is calculated.
analysis
explanatory variable
protein intake
objective variable
muscle and muscle mass change rate from baseline after 2 years
Management information
Registered date
| 2019 | Year | 07 | Month | 09 | Day |
Last modified on
| 2025 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042524
