Healthy adults
Conditions
Interventions
Consume one bottle of test food a day for 4 weeks - Washout 4 weeks - Consume one bottle of placebo food a day for 4 weeks
Consume one bottle of placebo food a day for 4 weeks - Washout 4 weeks - Cons
Sponsors
CPCC Company Limited
EZAKI GLICO CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy males and females aged 20 to 59 years old. (The ratio of men and women aim to be 1:2) (2) A half of female subjects aim to be the constipation tendency subjects who defecate 3 to 5 times in a week. (3) Subjects who do not regularly consume medicines, foods (which affect the intestinal environment) or supplements, during the examination period. (4) 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 for 1 week or more within 6 month before the test. (3) Subjects who have allergy to test food. (4) Smokers (5) Subjects who are heavy drinkers of alcohol. (6) Subjects who are living together (consort or partner etc.) has planned to participate to the same clinical test. (7) Subjects who plan big change of lifestyle during the test. (8) Subjects with tendency of chronic diarrhea. (9) Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart. (10) Subjects who suspected chronic or serious infectious disease. (11) Females who are pregnant (including the possibility of pregnancy) or are lactating. (12) Subjects who have participated the other clinical test within 1 month before the test. (13) 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. (14) Subjects who cannot refrain from consumption of medicines and foods which affect intestinal environment during the test. (15) Subjects who have been determined ineligible by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 16S rRNA gene-based metagenome analysis of gut microbiome and metabolome analysis of intestinal metabolites | — |
Secondary
| Measure | Time frame |
|---|---|
| * Defecation frequency * Property of stool * Volume of stool | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Planning & Sales Department
Outcome results
None listed