Healthy adult
Conditions
Sponsors
TTC Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Males and females from 20 to 64 years of age (2)Subjects who answered that the usual defecation frequency was 2 to 5 times per week in the questionnaire (3)Subjects with a tendency for constipation at 2 to 5 times of defecation per week during screening period
Exclusion criteria
Exclusion criteria: (1)Subjects who cannot restrict the use of medicines or health foods that may influence their bowel movements after informed consent (2)Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative (3)Subjects currently undergoing treatment with digestive diseases that affect the study or have a surgical history of digestive system (except appendicectomy) (4)Subjects with diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement or have a history of these diseases (5) Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) (6)Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality (7)Subjects need to be on medication or have a history of medication for serious diseases (8)Subjects have possibilities to develop an allergy to the test product (9)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (10)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (11)Subjects who have participated in other clinical studies (12)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating (13)Subjects judged as unsuitable for the study by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency, Defecation days. Evaluate two weeks after starting ingestion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Stool output, Fecal properties, Intestinal flora (Real-Time PCR) | — |
Countries
Japan
Contacts
Public ContactChiharu Goto
TTC Co., Ltd. Clinical Research Planning Department
Outcome results
None listed