Individuals with a tendency for constipation or loose stool
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Japanese males and females from 20 to 70 years of age. (2) Those with a tendency for constipation (at 4 times or less of defecation per week), and for loose stool (at 10 times or more of defecation per week). (3) Those taking regular meals.
Exclusion criteria
Exclusion criteria: (1) A medical history of severe disorders, or continuous medical treatment. (2) A surgical history of digestive system (except appendicectomy) (3) Watery stool daily (4) Those who are pregnant or have possibility to become pregnant during the study or breast-feeding. (5) Constantly usage of supplements and/or functional foods (including Food for Specified Health Uses [FOSHU]) affecting the test results. (6) Those having an extremely irregular diet habit, alternative work schedule, or work on midnight shift. (7) Those who drink alcohol a lot. (8) Withdrawal of whole blood more than 400mL within 12 weeks, or more than 200mL within 4 weeks, or withdrawal of blood components prior to the current study. (9) Those judged as unsuitable for the study by the principal investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency, defecation days, fecal condition | — |
Secondary
| Measure | Time frame |
|---|---|
| Intestinal microflora composition, organic acids, putrefactive products, questionnaire for QOL | — |
Countries
Japan
Contacts
Clinical Support Corporation PI-Food Service Division