UMIN-CTR Clinical Trial

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
Email	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/
Email	sangaku@aichi-med-u.ac.jp

Sponsor
Institute	Aichi Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017360