UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032482 |
|---|---|
| Receipt number | R000037038 |
| Scientific Title | A Randomized, Double-Blind Comparison Study of Royal Jelly to Improve Vascular Endothelial Function in Healthy Volunteers |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2021/11/07 09:47:01 |
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Basic information
Public title
A Randomized, Double-Blind Comparison Study of Royal Jelly to Improve Vascular Endothelial Function in Healthy Volunteers
Acronym
The effects of royal jelly on vascular endothelial function
Scientific Title
A Randomized, Double-Blind Comparison Study of Royal Jelly to Improve Vascular Endothelial Function in Healthy Volunteers
Scientific Title:Acronym
The effects of royal jelly on vascular endothelial function
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Medicine in general | Cardiology | Geriatrics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study assesses whether royal jelly improves endothelial function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of vascular endothelial function assessed by the change of rective hyperemia peripheral arterial tonometry (RH-PAT) index 4 weeks after administration of royal jelly supplements.
Key secondary outcomes
Secondary endpoints are the change of aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and gamma-glutamyl transpeptidase (gammaGT) for liver function and high-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C), and triglycerides.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Administration of capsuled royal jelly 690 mg daily (equivalent 2040 mg of fresh royal jelly) for 4 weeks.
Interventions/Control_2
Administration of placebo supplement for 4 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who did not meet following criteria were enrolled based on the results of medical interview;
1) subjects who have been diagnosed with diabetes, hypertension, or dyslipidemia in a previous physical examination or a health consultation
2) Patients undergoing treatment for diabetes, hypertension, and dyslipidemia
3) current smokers or those who have smoked within 1 year.
4) Participates who are confirmed their willingness to participate in this study and be obtained written consent afterexplanation of the study.
Key exclusion criteria
1) subjects who have been diagnosed with diabetes, hypertension, or dyslipidemia in a previous physical examination or a health consultation
2) current smokers or those who have smoked within 1 year.
3) Patients undergoing treatment for diabetes, hypertension, and dyslipidemia
4)patients with renal disease, gastrointestinal disease, heart disease, lung disease, neurological disease, endocrine disease, collagen disease, blood disease under medical treatment, or receiving any regular medications
5)receiving any regular medications
6)patients with serious complications, such as malignancy, or poor life expectancy
7)pregnant or potentially pregnant women
8) allergic to honey.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tsujita |
Organization
Kumamoto University
Division name
Department of Cardiovascular Medicine, Graduate School of Medical Sciences
Zip code
862-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan
TEL
81-96-373-5175
tsujita@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Fujisue |
Organization
Kumamoto University Hospital
Division name
Cardiovascular medicine
Zip code
862-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan
TEL
81-96-373-5175
Homepage URL
fujisues@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Sugi Bee Garden
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Human Ethics Review Committee of Kumamoto University
Address
1-1-1, Honjo, Chuo-ku, Kumaoto
Tel
81-96-373-5657
byi-senshin@jimu.kumamoto-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
| 2018 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.5551/jat.63044
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.5551/jat.63044
Number of participants that the trial has enrolled
100
Results
The percentage relative change in the RH-PAT index was significantly higher in the royal jelly group than in the placebo group (21.4%plusminus53.1% vs. 0.05%plusminus40.9%, P=0.037).
Results date posted
| 2021 | Year | 11 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age of the participants was 35.0plusminus9.3 years in the placebo group and 36.1plusminus9.1 years in the royal jelly groups; 45% and 50% of the placebo and the royal jelly groups, respectively, were male.
Participant flow
After acquisition of written informed consent, an independent investigator performed the randomization. Participants were randomly assigned to receive royal jelly 690 mg (equivalent 2040 mg of fresh royal jelly) or placebo daily for 4 weeks. Vascular endothelial function assessed on the basis of RH-PAT and blood chemistry were compared between baseline and 4 weeks after enrollment.
Adverse events
none
Outcome measures
The relative change in RH-PAT index.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 06 | Day |
Last modified on
| 2021 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037038
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