None (Healthy adults)
Conditions
Interventions
Food originated from a microorganism. 5 portion of food per day for 4 weeks.
Placebo food, 5 portion of food per day for 4 weeks.
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Males and females aged from 20 to less than 65 years old, when giving the informed consent. (2) Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
Exclusion criteria
Exclusion criteria: (1) Individuals who have a medical history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. (2) Individuals who have chronic diseases and use medicines continuously. (3) Individuals with excessive alcohol-drinking behaviors (Maximum daily quantity: Approximately 20 g of pure alcohol per day, for example, beer 1 bottle 500 mL, whiskey double 1 cup 60 mL, or wine approximately 1.5 cups 180 mL, respectively) . (4) Individuals who cannot stop drinking for two days until the screening and each checkup. (5) Individuals having food allergy. (6) Individuals who have a medical history of hay fever. (7) Individuals who have a medical history of diseases affecting digestion and absorption. (8) Individuals who have tendency to get diarrhea by eating dairy product. (9) Individuals who have a history of irritable bowel syndrome and Crohns disease. (10) Individuals who are judged as unsuitable for the study based on the results of blood test. (11) Individuals who have under treatment or a history of drug addiction and/or alcoholism. (12) Individuals who are participating or willing to participate in other clinical trials with the intake of food or pharmaceutical products, or with the swab of cosmetic or pharmaceutical products. (13) Individuals who are pregnant, breastfeeding, or planning to be pregnant in the near future. (14) Individuals who refuse to answer their biological sex. (15) Individuals who and whose family work for a company manufacturing or selling healthy foods or functional foods. (16) Individuals who are judged unsuitable for this study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Interview by physician 2. Height and body weight 3. Blood pressure and pulse 4. Hematological test 5. Blood biochemical analysis 6. Urine analysis 7. Subjective symptom and objective response 8. Adverse events | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Sales Department
Outcome results
None listed