Adult
Conditions
Interventions
Protease digested royal jelly Intake:2,400 mg Ingesion:28day
Brazilian green propolis containing food Intake:363 mg Ingesion:28day
Sponsors
Yamada Bee Company, Inc.
Research Center for Immunological Analysis. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactKohei Muroi
Yamada Bee Company, Inc. Institute for Bee Product & Health Science R&D development
Outcome results
None listed