UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014921 |
|---|---|
| Receipt number | R000017360 |
| Scientific Title | Effect of Exercise training and Royal jelly intake for muscle strength in Japanese elderly |
| Date of disclosure of the study information | 2014/08/21 |
| Last modified on | 2021/03/28 07:15:03 |
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Basic information
Public title
Effect of Exercise training and Royal jelly intake for muscle strength in Japanese elderly
Acronym
Effect of Exercise training and Royal jelly
Scientific Title
Effect of Exercise training and Royal jelly intake for muscle strength in Japanese elderly
Scientific Title:Acronym
Effect of Exercise training and Royal jelly
Region
| Japan |
Condition
Condition
Japanese elderly
Classification by specialty
| Geriatrics | Rehabilitation medicine | Not applicable |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although the effects of RJ on muscle strength are well discussed in older people, the combination of RJ and physical therapy treatment on the effect of exercise therapy is not discussed as such. Thus, in this study, we examine the effects of the RJ intake on bodily function of restoration in elderly rehabilitation subjects with exercise therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Functional measurement: grip, leg and trunk muscle strength
Physiology measurement: muscle mass volume
Key secondary outcomes
Functional measurement: TUGT (normal and maximum), one-leg standing duration
Physiology measurement: Height, weight, blood pressure, lung capacity, bone density
Blood test: General biochemical examination, IGF-1
Questionnaire: Locomotive Syndrome 25, MMSE and SDS.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
High level royal jelly intake group: P-RJ 4,320 mg/d (6 tablets/day of P-RJ)
Interventions/Control_2
Low level royal jelly intake group: Protease-Treated RJ 2,160 mg/day
Interventions/Control_3
Placebo group
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Over 60 years old, regularly come to the center at least 2 twice every month.
Able to walk themselves.
Able to join the research for as long as one year.
Key exclusion criteria
The person is involuntary to join the study.
The bone or joint deformity from the x-ray, causing the difficulty to judge the result of this study.
The person is fail to come to the center twice every month.
The person with asthma or food allergic.
The person with depressive symptom (from the SDS).
The person in charge who is unable to carry out the responsibility.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | TATSUNORI |
| Middle name | |
| Last name | IKEMOTO |
Organization
Aichi Medical University
Division name
Institute of Physical Fitness, Sports Medicine and Rehabilitation
Zip code
480-1195
Address
Nagakute
TEL
0561631087
tatsunon31@gmail.com
Public contact
Name of contact person
| 1st name | TATSUNORI |
| Middle name | |
| Last name | IKEMOTO |
Organization
Aichi medical university
Division name
Institute of Physical Fitness, Sports Medicine and Rehabilitation
Zip code
4801195
Address
Nagakute
TEL
0561631087
Homepage URL
https://www.aichi-med-u.ac.jp/
sangaku@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Farm. Inc
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
Aichi Medical University
Address
1-1 Yazako Karimata, Nagakute
Tel
0561-62-3311
amu_ethics@aichi-med-u.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 10 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 10 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 21 | Day |
Last modified on
| 2021 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017360
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
