UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061450 |
|---|---|
| Receipt number | R000070283 |
| Scientific Title | Postoperative Branched-Chain Amino Acid Supplementation Preserves Muscle Mass and Enhances Functional Recovery after Hip Fracture Surgery: A Randomized, Placebo-Controlled Trial |
| Date of disclosure of the study information | 2026/05/04 |
| Last modified on | 2026/05/04 18:13:12 |
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Basic information
Public title
Postoperative Branched-Chain Amino Acid Supplementation Preserves Muscle Mass and Enhances Functional Recovery after Hip Fracture Surgery: A Randomized, Placebo-Controlled Trial
Acronym
Postoperative Branched-Chain Amino Acid Supplementation Preserves Muscle Mass and Enhances Functional Recovery after Hip Fracture Surgery: A Randomized, Placebo-Controlled Trial
Scientific Title
Postoperative Branched-Chain Amino Acid Supplementation Preserves Muscle Mass and Enhances Functional Recovery after Hip Fracture Surgery: A Randomized, Placebo-Controlled Trial
Scientific Title:Acronym
Postoperative Branched-Chain Amino Acid Supplementation Preserves Muscle Mass and Enhances Functional Recovery after Hip Fracture Surgery: A Randomized, Placebo-Controlled Trial
Region
| Japan |
Condition
Condition
Hip Fracture
Classification by specialty
| Medicine in general | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate whether the administration of branched-chain amino acids (BCAAs) from the acute perioperative phase following proximal femoral fractures in frail elderly patients can lead to improvements in muscle recovery, nutritional status and functional outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mid-thigh cross-sectional area
Key secondary outcomes
alb, pre-alb, Tf, CRP, Lym, Tcho, TP, Hb,Barthel index, FIM, TUG, Standing-to-sitting repetition test, 3m time attack
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Take 2g of BCAA after every meal
Interventions/Control_2
Take 2 g of lactose after every meal
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
Patients aged 65 and over who have undergone surgery for a proximal femoral fracture
Key exclusion criteria
Patients who were refused participation in the study, patients who were unable to undergo surgery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | inoue |
| Middle name | |
| Last name | takanori |
Organization
Yoshimoto Orthopaedic and Surgical Hospital
Division name
orthopedic surgery
Zip code
639-2101
Address
676-7 hikida Katsuragi city Nara Japan
TEL
0745695353
nkn.tknr@gmail.com
Public contact
Name of contact person
| 1st name | Inoue |
| Middle name | |
| Last name | Takanori |
Organization
Yoshimoto Orthopaedic and Surgery Hospital
Division name
Orthopedic surgery
Zip code
639-2101
Address
676-1 Hikida Katsuragi city Nara Japan
TEL
0745695353
Homepage URL
nkn.tknr@gmail.com
Sponsor or person
Institute
Yoshimoto Orthopaedic and Surgery Hospital
Institute
Department
Personal name
Inoue Takanori
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yoshimoto Orthopaedic and Surgery Hospital
Address
676-1 Hikida Katsuragi city Nara Japan
Tel
0475695353
nkn.tknr@gmail.com
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
| 2026 | Year | 05 | Month | 04 | Day |
Related information
URL releasing protocol
no url
Publication of results
Unpublished
Result
URL related to results and publications
no url
Number of participants that the trial has enrolled
62
Results
The BCAA group showed significantly greater changes in the area of the muscular and total thigh area on the unaffected side between admission and week 3 compared with the placebo group.
The BCAA group also showed a significant improvement in transferrin levels and the Barthel Index compared with the placebo group in terms of the change from one week to three weeks post-surgery.
No statistically significant difference was observed between the two groups in other parameters.
Results date posted
| 2026 | Year | 05 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Characteristic
Placebo (n=31) BCAA (n=31)
p value
Age (years) 81.4 +- 10.2 81.0 +- 9.8 0.84
BMI (kg/m2) 20.12 +- 1.52 19.93 +- 1.26 0.82
Handgrip strength, right (kg) 13.0 +- 3.8 12.4 +- 2.7 0.45
FIM score
103.5 +- 9.6 99.5 +- 9.7 0.39
Barthel Index 78.0 +- 9.2 83.7 +- 9.0 0.09
Albumin (g/dL) 3.48 +- 0.15 3.46 +- 0.22 0.82
Transferrin (mg/dL) 200.2 +- 16.9 199.4 +- 17.0 0.09
Participant flow
Once a diagnosis of a proximal femoral fracture had been made during an outpatient consultation and it had been decided that the patient would undergo surgical treatment at our hospital, we explained the study to the patient. Upon obtaining their consent, we had them sign a consent form. Following the operation, the patient was instructed to take 2 g of BCAA or lactose after every meal for three weeks, starting from the day after the surgery.
Adverse events
none
Outcome measures
Total CSA ratio,Muscular CSA ratio, Barthel Index, Transferrin (mg/dL),Hemoglobin (g/dL),Albumin (g/dL),CRP (mg/dL),FIM score,Timed Up-and-Go test (sec),Grip strength, lower leg circumference, CONUT score, MNA
A t-test was used to compare the two groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 04 | Day |
Last modified on
| 2026 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070283
