healthy subjects
Conditions
Interventions
Study food 5 times of serving size per day for 4 weeks, safety evaluations are performed at 0, 2, 4 and 6 weeks
Control food 5 times of serving size per day for 4 weeks, safety evaluations are p
Sponsors
Maruzen Pharmaceuticals Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy males and females who equal to or more than 20 years and less than 65 years of age 2.Subjects who can visit the medical institution at the scheduled visit date 3. Subjects who are able to understand the study and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects who systolic blood pressure is less than 90 mmHg 2. Subjects who equal to or more than 25kg/m of BMI 3. Subjects who given surgery, or taken medication due to serious illness within a month 4. Subject who present heart, liver, kidney disorders 5. Subjects who are taking drugs, foods for specified health use or functional foods which could affect this study 6. Subjects who Females in pregnancy, lactation and scheduled pregnancy period 7 Subjects who with heavy use of alcohol, and heavy smoking 8. Subject who have been felt ill by blood collection 9. Subjects who donated 200 ml or more of blood within a month prior to the study 10 Subjects who with irregular eating habits(Night shift worker) 11. Subjects who plan business trip or trip for 10 consecutive days or more 12. Subjects who have allergy related to the test foods 13. Subjects who have chronic diarrhea or chronic coprostasis 14.Subjects who already participating in other clinical trials, or planning to participate during this examination period 15. Subjects who can not agree with prliminary explanation 16. Subjects who are deemed to be unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| < Safety> Side effect incidence, Adverse event incidence, clinical examination items, physiological examination items | — |
Countries
Japan
Contacts
Public ContactEndoh Yoshiki
New drug research center, Inc. Clinical Research Dept.
Outcome results
None listed