UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004057 |
|---|---|
| Receipt number | R000004890 |
| Scientific Title | Effect of Royal Jelly on muscle strength in free-living elderly people: A randomized controlled pilot study |
| Date of disclosure of the study information | 2010/08/17 |
| Last modified on | 2014/03/25 13:16:07 |
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Basic information
Public title
Effect of Royal Jelly on muscle strength in free-living elderly people: A randomized controlled pilot study
Acronym
Royal Jelly and sarcopenia
Scientific Title
Effect of Royal Jelly on muscle strength in free-living elderly people: A randomized controlled pilot study
Scientific Title:Acronym
Royal Jelly and sarcopenia
Region
| Japan |
Condition
Condition
Sarcopenia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of Royal Jelly versus placebo on muscle strength in elderly people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
grip strength, one-leg standing duration with vision, 5-meter maximum walk test, timed up and go test
Key secondary outcomes
Cortisol, Dehydroepiandrosterone-Sulfate (DHEA-S), etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Control (placebo)
Interventions/Control_2
low-does Royal Jelly (Royal Jelly: 1.2g/d)
Interventions/Control_3
high-does Royal Jelly (Royal Jelly: 4.8g/d)
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
self-independent elderly living at home
Key exclusion criteria
allergic constitution, visual and hearing impairment, depression, dementia, etc.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Niu Kaijun |
Organization
School of Public Health, Tianjin Medical University
Division name
Department of Epidemiology
Zip code
Address
22 Qixiangtai Road, Heping District, Tianjin 300070, China
TEL
+86-13114814477
nkj0809@163.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Niu Kaijun |
Organization
School of Public Health, Tianjin Medical University
Division name
Department of Epidemiology
Zip code
Address
22 Qixiangtai Road, Heping District, Tianjin 300070, China
TEL
+86-13114814477
Homepage URL
nkj0809@163.com
Sponsor or person
Institute
School of Public Health, Tianjin Medical University
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Farm Co.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 08 | Month | 17 | 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
Royal jelly treatment may be effective in
preventing muscle strength decline in elder people.
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
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 17 | Day |
Last modified on
| 2014 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004890
