healthy individuals
Conditions
Interventions
Ingestion of test food A for 12 weeks
Ingestion of test food B for 12 weeks
Ingestion of control food substance for 12 weeks
Sponsors
Miura Clinic, Medical Corporation Kanonkai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Subjects of men and women aged 20 to 64 (2) Subjects feeling tired (3) Subjects who feel their body is weakening (4) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Exclusion criteria
Exclusion criteria: (1) Subjects with a history of diabetes, liver disease, renal disease, digestive system disease, heart disease, respiratory disease, peripheral angiopathy, and other diseases that may affect the results of this study, or subjects with surgical history (2) Subjects with abnormal liver function and renal function test values (3) Subjects with diseases currently being treated (4) Subjects with food and drug allergies (5) Subjects taking warfarin (6) Subjects with anemia symptoms (7) Subjects on a diet (8) Subjects with irregular lives (9) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (10) Subjects who are continuously taking medicines (including OTC and prescription medicines) (11) Subjects who are excessively ingesting alcohol (12) Subjects who cannot stop drinking from the day before the test to the day of the test (13) Pregnant persons or subjects who are planning to become pregnant or breastfeed during the test period (14) Subjects who are participating in or will participate in other clinical trials at the start of this study, and within 4 weeks after the end of the study. (15) Other subjects judged by the investigator to be inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of the common cold (upper respiratory tract infections, influenza, tiredness), Wisconsin upper respiratory symptom survey-21 (WURSS-21), Salivary S-IgA, immunity evaluation, Subjective indicators of health-related quality of life | — |
Countries
Japan
Contacts
Public ContactMakoto Terashima
Oneness Support Co., Ltd. Clinical Trial Division
Outcome results
None listed