Healthy adult
Conditions
Interventions
Sponsors
Eligibility
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 5 or less per week in the questionnaire (3)Subjects with constipation tendency and lower defecation frequency 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 are regularly using commercially available constipation medicine (3)Subjects currently undergoing treatment or 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 have a deseases requiring regular medication or a history of serious diseases for which medication was required (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 Evaluate two weeks after starting ingestion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation days, Fecal amount, Fecal properties. Intestinal flora(Real-Time PCR). Fecal moisture. Fecal pH. The fecal concentrations of ammonia. | — |
Countries
Japan,South America
Contacts
TTC Co., Ltd. Clinical Research Planning Department