healthy subjects
Conditions
Interventions
Subjects receive 2400 mg/day of enzymatic degradation royal jelly for 12 weeks
Subjects receive placebo for 12 weeks
Sponsors
Other
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in blood LBP concentration from baseline at 12 weeks of intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline 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 | — |
Countries
Japan
Contacts
Public ContactMasaki Igarashi
The University of Tokyo Hospital Department of Diabetes and Metabolism Diseases
Outcome results
None listed