UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056079 |
|---|---|
| Receipt number | R000064040 |
| Scientific Title | Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effect of royal jelly on the intestinal environment in elderly persons |
| Date of disclosure of the study information | 2024/11/06 |
| Last modified on | 2024/11/06 15:12:14 |
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Basic information
Public title
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effect of royal jelly on intestinal environment in elderly persons
Acronym
The study to evaluate the effect of royal jelly on the intestinal environment in elderly persons
Scientific Title
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effect of royal jelly on the intestinal environment in elderly persons
Scientific Title:Acronym
The study to evaluate the effect of royal jelly on the intestinal environment in elderly persons
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of royal jelly oral administration on the intestinal environment in elderly persons.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in blood LBP concentration from day 0 at 12 weeks of intake
Key secondary outcomes
Change from day 0 of intake at 12 weeks of intake of the items listed below
Physical measurements (height, weight, body composition (BIA method), waist circumference, lower leg circumference, grip strength), laboratory tests (hematological tests, blood biochemical tests, B cell count, T cell count, NK cell count), blood picture (monocyte count, neutrophil count, eosinophil count, basophil count), blood zonulin concentration, hematopoietic stem cell count, intestinal flora, short chain fatty acid concentration in feces, questionnaire
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
Subjects receive 2400 mg/day of enzymatic degradation royal jelly for 12 weeks
Interventions/Control_2
Subjects receive placebo for 12 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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)The healthy subjects who agree to the study
2)The healthy subjects who are able to understand and comply with the administrative matters for the duration of the said examination
3)The healthy subjects who are deemed eligible by the principal investigator or principal investigator in his/her overall judgment
Key exclusion criteria
1)Persons with food allergies or asthma, or with a history of such allergies or asthma
2)Persons who take supplements, foods, or beverages containing royal jelly on a daily basis
3)Those who are unable to stop taking or consuming medicines and health foods that affect the test results from the time consent is obtained until the completion of the test.
4)Persons who are unable to stop taking or consuming foods or beverages from the time of consent until the end of the study.
5)Persons who do not agree to make any significant changes in the type and amount of fermented foods they consume during the study period.
5)Persons who are scheduled to undergo tests that may cause significant changes in the intestinal microbiota, such as laxatives during the study period.
6)Persons who are judged to be depressed based on the results of PHQ-9 of the screening test
7)Persons with diseases of the gastrointestinal tract, liver, kidney, heart, and circulatory system that affect absorption, distribution, metabolism, or excretion of the test food
8)Persons with a history of major surgery on the gastrointestinal tract site, such as gastrectomy, gastrointestinal suture, or intestinal resection
9)Persons who have serious hepatic disorder, renal or cardiac disease, organ disorder, diabetes mellitus, or other serious illness
10)Consume more than 60 g of alcohol per day on a daily basis.
11)Smoking more than 21 cigarettes per day on a daily basis.
12)Persons who have irregular lifestyle due to night work, shift work, etc.
13)Persons who cannot maintain a regular lifestyle
14)Persons who have had blood samples exceeding 200 mL within 4 weeks or 400 mL within 3 months prior to the start of the study.
15)Participated or currently participating in another clinical trial in the past 3 months.
16)Persons living in the same household who are participating or will participate in this clinical study.
17)Persons who are judged to be ineligible by the principal investigator or research assistant.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Igarashi |
Organization
The University of Tokyo Hospital
Division name
Department of Diabetes and Metabolic Diseases
Zip code
113-8655
Address
7-3-1 Hongo Bunkyo-ku
TEL
03-3815-5411
igarashi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Igarashi |
Organization
The University of Tokyo Hospital
Division name
Department of Diabetes and Metabolism Diseases
Zip code
113-8655
Address
7-3-1 Hongo Bunkyo-ku
TEL
03-3815-5411
Homepage URL
igarashi-tky@umin.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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 University of Tokyo, Clinical Research Review Board
Address
7-3-1 Hongo Bunkyo-ku
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2024 | Year | 11 | Month | 06 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 06 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064040
