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 per
Sponsors
Maruzen Pharmaceuticals Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy males and who females 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 30kg/m2of BMI. 3. Subjects who fall under diagnostic criteria of metabolic syndrome 4. Subjects who given surgery, or taken medication due to serious illness within a month 5. Subject who present heart, liver, kidney disorders. 6. Subjects who are taking drugs, foods for specified health use or functional foods which could affect this study. 7. Subjects who Females in pregnancy, lactation and scheduled pregnancy period. 8. Subjects who with heavy use of alcohol, and heavy smoking. 9. Subject who have been felt ill by blood collection. 10. Subjects who donated 200 ml or more of blood within a month prior to the study 11.Subjects who with irregular eating habits.(Night shift worker) 12. Subjects who plan business trip or trip for 10 consecutive days or more. 13. Subjects who have allergy related to the study foods 14. Subjects who have chronic diarrhea or chronic coprostasis 15. Subjects already participating in other clinical trials, or planning to participate during this examination period 16. Subjects who can not agree with preliminary explanation 17. 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