Healthy subjects with a tendency for constipation
Conditions
Interventions
Continuous intake of the test food
Continuous intake of the placebo food
Sponsors
FUKUOKA KINEN PET KENSHIN CENTER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese males and females between the ages of 40 and 64 years old at the time of obtaining consent to participate in the study. 2. Subjects with tendency of constipation. 3. Subjects available at every designated visit. 4. Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with hepatic, renal, cardiac or organ disorders or diabetes or other serious diseases. 2. Subjects with a surgical history of digestive system (except appendicectomy). 3. Subjects currently under treatment with chronic diseases. 4. Subjects with food allergies to the food ingredients used in the test. 5. Subjects who cannot refrain from ingesting lactic acid bacteria and dietary fiber-enriched foods that may affect on the intestinal functions from 1 week before ingestion of test food to the final stool collection day. 6. Subjects who wish to become pregnant during the study period (including the possibility of pregnant) or who are lactation or pregnant. 7. Heavy drinkers (average amount of intake as pure alcohol is 60 g or more per day). 8. Subjects who are participating in clinical trials or monitors other than this study or who are planning to participate during this study period. 9. Subjects who have donated or plan to donate 200 ml or more of blood separately from this study from 1 month before the primary screening to the end of the study. 10. Subjects who frequently skip food. 11. Subjects who work from 22:00 to 6:00 (shift worker, night- shift worker, etc). 12. Subject who cannot consume foods whose origin is not clearly indicated due to religious or other reasons. 13. Subjects judged as unsuitable for this study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The analysis of the stool and defecation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective symptom | — |
Countries
Japan
Contacts
Public ContactIsao Takehara
Clinical Support Corporation Limited Food Service Division
Outcome results
None listed