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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000017629
Receipt No. R000020428
Scientific Title The effect of royal jelly on prevention of postmenopausal bone loss.
Date of disclosure of the study information 2015/05/20
Last modified on 2020/11/24

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Basic information
Public title The effect of royal jelly on prevention of postmenopausal bone loss.
Acronym Royal jelly and postmenopausal bone loss
Scientific Title The effect of royal jelly on prevention of postmenopausal bone loss.
Scientific Title:Acronym Royal jelly and postmenopausal bone loss
Region
Japan

Condition
Condition Postmenopausal bone loss
Classification by specialty
Endocrinology and Metabolism Obsterics and gynecology Orthopedics
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of royal jelly on prevention of postmenopausal bone loss.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone mineral density, bone turnover markers
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Freeze dried law royal jelly 3,000mg/day (1,000mg as active ingredient) for 6 months.
Interventions/Control_2 Placebo
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
45 years-old <=
Age-upper limit
60 years-old >=
Gender Female
Key inclusion criteria Healthy women (without risks of fracture) within 5 years of post-menopause.
Key exclusion criteria Women who are allergic to royal jelly, women with asthma, women who have complications and medications that would affect bone metabolism, and women who need osteoporosis medication.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Matsushita
Organization AIchi Medical University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code 480-1195
Address 1-1 Yazakokarimata, Nagakute, Aichi 480-1195
TEL 0561-62-3311
Email hirosm@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Matsushita
Organization Aichi Medical University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code 480-1195
Address 1-1 Yazakokarimata, Nagakute, Aichi 480-1195
TEL 0561-62-3311
Homepage URL
Email hirosm@aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University School of Medicine
Institute
Department

Funding Source
Organization Japan Royal Jelly Fair Trade Council
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Aichi Medical University School of Medicine
Address 1-1 Yazakokarimata, Nagakute, Aichi 480-1195
Tel 0561-62-3311
Email syomu@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 愛知医科大学

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 20 Day

Related information
URL releasing protocol https://www.tandfonline.com/doi/full/10.1080/13697137.2020.1806815
Publication of results Published

Result
URL related to results and publications https://www.tandfonline.com/doi/full/10.1080/13697137.2020.1806815
Number of participants that the trial has enrolled 72
Results 1) Although women in the placebo group experienced a significant loss of BMD and deterioration in HSA parameters of the femur, no significant differences were found in these parameters in women in the RJ group.
2) The levels of P1NP and TRACP-5b decreased significantly in the placebo group; however, the total P1NP level, a marker of bone formation, was not significantly different in the RJ group at postintervention compared with baseline.
Results date posted
2020 Year 11 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 09 Month 03 Day
Baseline Characteristics Seventy-two healthy postmenopausal women aged 45-60?years within 5?years after menopause.
Participant flow Participants were randomized into two groups: women in the RJ group (n?=?36) received capsules containing dried RJ (equivalent to 3000?mg of fresh RJ); and women in the placebo group (n?=?36) received placebo daily for 6?months.
Adverse events None
Outcome measures Bone mineral density (BMD) of the lumbar spine (L2-L4) and left proximal femur, hip structural analysis (HSA) of the left hip, and bone turnover markers were measured.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 04 Month 24 Day
Date of IRB
2015 Year 04 Month 24 Day
Anticipated trial start date
2015 Year 05 Month 20 Day
Last follow-up date
2016 Year 03 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 20 Day
Last modified on
2020 Year 11 Month 24 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020428

Research Plan
Registered date File name
2020/11/24 Royal Jelly Trial 研究計画書.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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