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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033667
Receipt No. R000038355
Scientific Title Evaluation trial whether honeybee products vary intestinal environment that intended for healthy individuals
Date of disclosure of the study information 2020/01/31
Last modified on 2018/10/18

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Basic information
Public title Evaluation trial whether honeybee products vary intestinal environment that intended for healthy individuals
Acronym Evaluation trial whether honeybee products vary intestinal environment that intended for healthy individuals
Scientific Title Evaluation trial whether honeybee products vary intestinal environment that intended for healthy individuals
Scientific Title:Acronym Evaluation trial whether honeybee products vary intestinal environment that intended for healthy individuals
Region
Japan

Condition
Condition Adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will evaluate whether usual intake of "lyophilized powder of enzymatic degradated Royal jelly" and "Brazilian green propolis" for 4 weeks modulate intestinal microbioita and intestinal environment that intended for healthy Japanese men and women who are older than 60 years.

We will evaluate intestinal regulating action throught daybook and safety through physical examinations (interviews, auscultation, percussion, inspection, palpation, etc.) and side effects and changes in clinical laboratory values from the baseline evaluation (vist0, week0) to the last evaluation (visit3, week 4).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We will evaluate composition of intestinal microbiota of each fecal sample by genetic engenieering method, and short-chain, water-soluble, and low molecular compounds of fecal samples will be instrumentaly analyzed both quantitatively and qualitatively.
(Measuring before and after 4 week intervention)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Protease digested royal jelly
Intake:2,400 mg
Ingesion:28day
Interventions/Control_2 Brazilian green propolis containing food
Intake:363 mg
Ingesion:28day
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 Target subjects must satisfy the following selection criteria.

1. Healthy Japanese men and women (only menopause statement) aged more than 60 years, at the time of giving informed consent.
2. A person who had experienced defecation from 2days to 5 days during 7 days just before visiting clinic in the period of observation. (Not nessesary to consecutive days)
3. A person who is not using drugs or medical equipment regardless of seasonal, chronic, or unexpected, and is not undergoing rehabilitation therapy.
4. A person who has freely given consent and has understood the purpose of the clinical study.
5. A person whose BMI is 18.5 - 25.0.
6. A person who can refrain from excessive exercise during the clinical study.
7. A person who can take three meals a day basically and refrain from great intemperance during the clinical study.
8. A person who understands that clinical visits are mandatory during clinical study period.
9. A person who is considered fit for the enrollment in the clinical study.
10. A person who doesn't take drugs and supplements that affect intestinal environment during the clinical study.
Key exclusion criteria The subjects in conflict with any of the following condition are excluded.

1. A person who took Royal jelly, or Propolis supplement even once within 1month at the time of giving informed consent.
2. A person who took drugs such as antibiotics and dietary supplements that may affect examination outocome.
3. A person who cannot agree with not changing the kind and amount of famous fermented foods such as miso, sake, vinegar, yogurt, cheese, kimch, and natto from past lifestyle.
4. A person who has chornic diarrhea easily.
5. A person who takes commercially available laxatives.
6. A person who smokes even once within 1month at the time of giving informed consent.
7. A person who has a food allergy or asthma.
8. A person who has a disorder to absorption, distribution, metabolism, excretion of trial food, such as digestive tract, liver, kidney, heart and cardiovascular system.
9. A person with a history of cerebrovascular disorder and cranial nerve disorder.
10. A person who is suspected alcohol or drug dependence
11. A person who has taken the blood sampling either 200 mL within 4 weeks or 400ml within 3 months at the time of starting this clinical study.
12. A person who participated in other clinical trial including patch test of cosmetics at present and last 3 months.
13. A person who has an irregular habit because of working at night or working under work-shift form.
14. A person whose housemate are participating or willing to participate this clinical study.
15. A person who cannot follow management matter during clinical study period.
16. A person who has a plan to change own lifestyle dramatically, such as travelling to, or staying developing countries during clinical study period.
17. A person who has a plan to be examined with microscopy during clinical study period.
18. A person who had been judged not appropriate as test subject by questionnaire about lifestyle.
19. A person who had been judged not appropriate by principal investigator.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Sugimoto
Organization Medical corporation Koganeibasi Sakura Clinic
Division name Not applicable
Zip code
Address 2-11-25 Sakuramachi, Koganei-city, Tokyo, 184-0005, Japan
TEL 042-382-5101
Email info@kb-clinic.com

Public contact
Name of contact person
1st name
Middle name
Last name Kohei Muroi
Organization Yamada Bee Company, Inc.
Division name Institute for Bee Product & Health Science R&D development
Zip code
Address 194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL 0868-54-3825
Homepage URL
Email km1730@yamada-bee.com

Sponsor
Institute Yamada Bee Company, Inc.
Institute
Department

Funding Source
Organization Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Research Center for Immunological Analysis. Inc.
Name of secondary funder(s) none

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2020 Year 01 Month 31 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 No longer recruiting
Date of protocol fixation
2018 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 07 Day
Last modified on
2018 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038355

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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