Healthy male/female adults
Conditions
Interventions
Consume 100 g of the test food every morning for 4 weeks.
Consume 100 g of the control food every morning for 4 weeks.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Males and females aged more than or equal to 20, and less than 40 when obtaining the consent. (2) Subjects without chronic diarrhea symptoms. (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 have a plan or who have taken medication which would affect the trial result (e.g. drugs for anti-allergic, intestinal disorder, and laxative) after pre-inspection 1. (2)Subjects who have a plan or who have taken antibiotics within 3 months prior to the trial. (3)Subjects who are regularly consuming food for specified health uses (FOSHU), food with function claims, supplement and/or health foods which would affects the trial results for more than 3 days a week. (4)Subjects who have removed tonsils and/or appendix. (5)Subjects whose roomer is planning to join this trial. (6)Subjects who have received the surgery which would affect the trial result (e.g. colonoscopy, removal of gallstones and/or gall bladder, or gastric bypass surgery) within half a year before obtaining the consent. (7)Pregnant, possibly pregnant, or lactating women. (8)Subjects who have current medical history/anamnesis of severe cardiac, hepatic, renal or digestive diseases. (9)Subjects who take excessive alcohol. (10)Subjects who would encounter a dramatic change in their living environment (e.g. relocation, job-changing). (11)Subjects with irregular dietary habits or lifestyle (e.g. alternative work schedule, graveyard shift). (12)Subjects who are allergic to drugs or foods. (13)Subjects who are participating or have been participated to other clinical tests with specific medicine/food within the last 4 weeks before this trial, or planning to join those after giving informed consent. (14-16)Subjects who donated their blood components and/or whole blood prior to the pre-inspection as follows; - any subjects: 200 mL within a month - males: 400 mL within the last 3 months - females: 400 mL within the last 4 months. (17-18)Subjects whose collected blood volume within the last 12 months would reach to following criteria after adding the blood collection in this study; - males: 1,200 mL - females: 800 mL (19)Others who have been determined ineligible by principal/sub investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut environment (gut microbiota and gut metabolites) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Defecation status (the number of days, frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor) 2. Biological barrier parameters (salivary IgA level, salivary IgA concentration, ratio of polymerized IgA in saliva, salivary mucin level, salivary mucin concentration, saliva volume, salivary chemokine ligand 28 level, salivary chemokine ligand 28 concentration, serum LPS binding protein concentration, serum zonulin concentration, serum high-sensitivity C-reactive protein concentration, serum inflammatory cytokines concentration, plasma metabolites) 3. Changes in clinical examination value 4. POMS2 short version 5. SF-36v2 Japanese version | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed