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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025617
Receipt No. 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

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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
Email 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
Email mkoga@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Department of Psychiatry
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029369

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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