Healthy volunteer
Conditions
Interventions
Single oral intake of 10 mg of test food
Single oral intake of 50 mg of test food
Single oral intake of 250 mg of test food
Sponsors
Shinanozaka Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese healthy male and female applicants whose age at the time of obtaining consent is 40 years or older (male / female ratio 1: 1 or male <female) 2)Person with a BMI of 18.5 or more and less than 25.0 at the time of screening test 3)Those who are judged to be eligible as subjects of this study by the investigator, etc. in consideration of the results of the screening test 4)Those who have received sufficient explanation about the purpose and contents of this test, voluntarily volunteered, and consented in writing to participate in the test.
Exclusion criteria
Exclusion criteria: 1) Those who are treated by a doctor or dentist 2) Persons with or have a history of hypersensitivity or idiosyncrasy to drugs or food 3) Person with allergic diseases such as bronchial asthma, hay fever, and atopic dermatitis 4) Those who have diseases in the heart, liver, kidney, digestive organs, respiratory organs, blood function, etc., or those who have a history of them or have a large surgical history, and are not eligible for this study by the investigator Those who are judged to be (excluding appendectomy) 5) Those who are or may be allergic to ellagic acid-containing foods (pomegranates, berries, nuts, etc.) 6) Those who are confirmed to be positive in the immunological test at the time of screening test 7) Person who regularly use foods for specified health use, foods with functional labeling foods and dietary supplements (supplement foods such as capsules) and cannot stop their intake at the time of obtaining consent. 8) Those who cannot keep smoking cessation during the period of admission and prohibition of drinking from 2 days before admission to the time of leaving 9) Those who cannot comply with not taking from ingesting ellagic acid-containing foods (pomegranates, berries, nuts, etc.) from 7 days before entering the hospital until leaving the hospital. 10) Those who have used or took the drug within 1 week before ingesting the test food, or those who need to use or take the drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Comparative trial of blood Urolithin A concentration 2) Comparative trial of urinary Urolithin A concentration 3) Comparative trial of Urolithin A concentration in feces 4) Safety evaluation | — |
Countries
Japan
Contacts
Public ContactMiki Sasaki
Shinanozaka Clinic Clinical Trial Department
Outcome results
None listed