Healthy adults
Conditions
Interventions
Consume two tablets of test food with water a day for 4 weeks - Washout 4 weeks - Consume two tablets of placebo food with water a day for 4 weeks
Consume two tablets of placebo food with water a day
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy males and females aged 20 to 59 years old. (2) Subjects who defecate less than and equal to 5 times in a week. (3) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Exclusion criteria
Exclusion criteria: (1) Subjects who didn't undergo abdominal surgical operation within 6 month before the test. (2) Subjects who didn't take antibiotics within 1 month before the test. (3) Subjects who have allergy to test food. (4) Subjects who are heavy drinkers of alcohol. (5) Subjects who plan big change of lifestyle during the test. (6) Subjects with tendency of chronic diarrhea. (7) Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver functions, kidney functions, cardiovascular system and digestive systems. (8) Subjects who suspected serious infectious disease. (9) Females who are pregnant (including the possibility of pregnancy) or are lactating. (10) Subjects who have participated the other clinical test within 1 month before the test. (11) Subjects who have consumed medicines and/or foods which affect intestinal environment (yogurt, lactic acid bacteria beverage, oligo-sugar, dietary fiber) in the last 2 weeks before the day of preliminary examination. (12) Subjects who have a plan to start consuming medicines and/or foods which affect intestinal environment (yogurt, lactic acid bacteria beverage, oligo-sugar, dietary fiber) during examination. (13) Subjects who donated over 200mL blood and/or blood components within a month to the current study. (14) Males who donated over 400mL blood within the last 3 months to the current study. (15) Females who donated over 400mL blood within the last 4 months to the current study. (16) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study. (17) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study. (18) Others they have been determined ineligible by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Defecation frequency *Volume of stool | — |
Secondary
| Measure | Time frame |
|---|---|
| *Property of stool *Color of stool *Gut microbiota *Spoilage products in stool *Short-chain fatty acids in stool | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Planning & Sales Department
Outcome results
None listed