UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017629
Receipt number 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 11:43:58

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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 Obstetrics 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 or person

Institute

Aichi Medical University School of Medicine

Institute

Department

Personal name



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

Value
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