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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004057
Receipt No. 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

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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
Email 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
Email nkj0809@163.com

Sponsor
Institute School of Public Health, Tianjin Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004890

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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