Healthy male/female adults
Conditions
Interventions
ingestion of the test capsules with water for 4 weeks
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women between the ages of 20 and 64 at the moment of consent. 2. Those who defecate between 3 and 5 times a week. 3. Those who have received a full explanation of the study can understand the contents and give written consent.
Exclusion criteria
Exclusion criteria: (1) Those who have consumed or will consume oligosaccharide-containing foods for specified health uses or health foods one month before start of test food consumption (2) Those who regularly consume food for specified health use, or health foods that potentially affect the study at least 3 times a week (3) Those who regularly consume foods that potentially affect the test food more than 3 times a week (4) Those who will have taken any medication that will affect the study one month before the pre-test (5) Those who are lactose intolerant (6) Patients with a history of appendectomy (7) Those who underwent surgery that may have affected the study within six months before obtaining consent (8) Heavy alcohol drinkers (9) Those who are planning major changes in their environment during the study period (10) Those with irregular eating habits or irregular lifestyle (11) Those living in the same household who plan to participate in the study (12) Those who are participating in a clinical trial of another drug or health food within 4 weeks after completion of the study, or planning to participate in another clinical trial after participating in the study (13) Patients with a history of heart, liver, kidney, or gastrointestinal diseases (14) Those who are pregnant, lactating, or intending to become pregnant during the study (15) Those who are allergic to drugs/foods (16) Those who have donated 200 mL of blood in one month before start of the study (17) Males who have donated 400 mL of blood within 3 months before start of the study (18) Females who have donated 400 mL of blood within 4 months before start of the study (19) Males whose blood collected in the 12 months before study plus the expected blood for the study exceeds 1200 mL (20) Females whose blood collected in the 12 months before study plus the expected blood for the study exceeds 800 mL (21) Those who are judged by the investigator or sub-investigator to be inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation status (fecal properties, and frequency of defecation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation status (the number of the days of defecation, quantity of defecation, color of stool, feeling of residual stool during defecation, abdominal pain during defecation, odor) Intestinal microbiota Intestinal metabolites Blood LPS GSRS (Gastrointestinal Symptom Rating Scale) SF-8 Abdominal symptoms (distention, rumbling, and gas) at times other than defecation | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed