Healthy adults
Conditions
Interventions
Take 1 tablet of test food at a time, 3 times a day after every meal, for 28 days -- Washout 4 weeks --Take 1 tablet of placebo at a time, 3 times a day after every meal, for 28 days
Take 1 tablet of
Sponsors
CPCC Company Limited
DAIICHI SANKYO HEALTHCARE CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy males and females aged 30 to 49 years old. (Target half a ratio of men and women) 2) Subjects who defecate 3 to 5 times in a week. 3) Subjects who do not routinely use medicines or the gastrointestinal related health foods 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)Subject who concern difficult to carry out skin test, due to having birthmarks, scratches and a lot of acne on the skin. 2) Subject who have undergone abdominal surgery within 6 months. 3) Subject who took antibiotics within 6 months. 4) Subject who have allergy to the test food. 5) Smoker 6) Subjects whose consort or partner also participates to same clinical test. 7) Subjects who plan big change of lifestyle during test period. 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 or are lactating. And/or females who are the possibility of pregnancy. 12) Subjects who have participated in other clinical studies within 3 months. 13) Subjects who routinely use food for specific health use, functional foods and/or health foods. 14) Other subjects who have been determined ineligible by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Improvement of bowel movement *Evaluation of intestinal microbiota by 16S metagenomic analysis * Evaluation of intestinal metabolites by metabolome analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| * Skin tests * The incidence of adverse events * The incidence of side effects | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Planning & Sales Department
Outcome results
None listed