UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025617 |
|---|---|
| Receipt number | R000029369 |
| Scientific Title | Effects of royal jelly on improvement of brain function |
| Date of disclosure of the study information | 2017/01/11 |
| Last modified on | 2019/07/20 11:37:42 |
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Basic information
Public title
Effects of royal jelly on improvement of brain function
Acronym
Effects of royal jelly on improvement of brain function
Scientific Title
Effects of royal jelly on improvement of brain function
Scientific Title:Acronym
Effects of royal jelly on improvement of brain function
Region
| Japan |
Condition
Condition
Psychiatric disorders
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effect of royal jelly on psychological state, neurophysiological function of the central nervous system, sleep quality and cognitive function, and biochemical changes related to the health status of the brain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Survey 8 weeks after administration
Electroencephalography (event-related potential P3a & P3b, mismatch negativity, evoked gamma rhythms, and auditory evoked potentials)
Key secondary outcomes
Questionnaires (BDI, PANAS)
Evaluation of cognitive function (attention network test, word frequency test, digit symbol substitution test, verbal learning test, effort based decision making test)
MRS (measurement of glutathione, NAA, NAAG, glutamate, glutamine)
Biochemical analysis (sleep-wake cycle-related hormones, inflammatory factors, stress-related hormones)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test material: Dried royal jelly powder
Duration: 8 weeks
Dose: Daily 1000mg (equivalent to 3000 mg of fresh Royal Jelly)
Interventions/Control_2
Test material: Placebo
Duration: 8 weeks
Dose: Casein 500mg, carbohydrate 90mg, lipid 24mg (equivalent amounts of protein, carbohydrate, and lipid contained in 3000 mg of royal jelly)
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Men and women aged 30 to 75 years old
(2) BMI of more than 25
Key exclusion criteria
(1) Those who are being treated for psychiatric or neurological diseases
(2) Those who are diagnosed metabolic syndrome and currently being treated
(3) Those who currently have or previously had asthma
(4) Those who currently have or previously had food allergies
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Atsuhito |
| Middle name | |
| Last name | Toyomaki |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
060-8638
Address
Kita-15 Nishi-7 Kita-ward Sapporo Hokkaido, Japan
TEL
011-706-5160
mkoga@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Atsuhito |
| Middle name | |
| Last name | Toyomaki |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
060-8638
Address
Kita-15 Nishi-7 Kita-ward Sapporo Hokkaido, Japan
TEL
011-706-5160
Homepage URL
mkoga@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Department of Psychiatry
Institute
Department
Personal name
Funding Source
Organization
The JAPAN Royal Jelly Fair Trade Council
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
The Institutional Ethical Board for Epidemiological Studie
Address
Kita-15 Nishi-7 Kita-ward Sapporo Hokkaido, Japan
Tel
011-706-5003
shomu@med.hokudai.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
16-013
Org. issuing International ID_1
The Institutional Ethical Board for Epidemiological Studies at Hokkaido University Graduate School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 11 | 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
48
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Preparing for publication
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
| 2016 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 11 | Day |
Last modified on
| 2019 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029369
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
