Unique ID issued by UMIN | UMIN000033667 |
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Receipt number | 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 | 2022/05/19 09:31:09 |
Evaluation trial whether honeybee products vary intestinal environment that intended for healthy individuals
Evaluation trial whether honeybee products vary intestinal environment that intended for healthy individuals
Evaluation trial whether honeybee products vary intestinal environment that intended for healthy individuals
Evaluation trial whether honeybee products vary intestinal environment that intended for healthy individuals
Japan |
Adult
Adult |
Others
NO
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).
Safety,Efficacy
Confirmatory
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)
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
2
Prevention
Food |
Protease digested royal jelly
Intake:2,400 mg
Ingesion:28day
Brazilian green propolis containing food
Intake:363 mg
Ingesion:28day
60 | years-old | <= |
Not applicable |
Male and Female
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.
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.
24
1st name | |
Middle name | |
Last name | Masayuki Sugimoto |
Medical corporation Koganeibasi Sakura Clinic
Not applicable
2-11-25 Sakuramachi, Koganei-city, Tokyo, 184-0005, Japan
042-382-5101
info@kb-clinic.com
1st name | |
Middle name | |
Last name | Kohei Muroi |
Yamada Bee Company, Inc.
Institute for Bee Product & Health Science R&D development
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
0868-54-3825
km1730@yamada-bee.com
Yamada Bee Company, Inc.
Yamada Bee Company, Inc.
Profit organization
Research Center for Immunological Analysis. Inc.
none
NO
2020 | Year | 01 | Month | 31 | Day |
Unpublished
Completed
2018 | Year | 08 | Month | 07 | Day |
2018 | Year | 08 | Month | 21 | Day |
2018 | Year | 08 | Month | 24 | Day |
2018 | Year | 12 | Month | 31 | Day |
2018 | Year | 08 | Month | 07 | Day |
2022 | Year | 05 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038355
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