Healthy adult male/female subjects
Conditions
Interventions
Ingesting the test food by replacing the staple food (carbohydrates) with a piece of microwaved test food in either breakfast, lunch, or dinner.
Ingesting the placebo food by replacing the staple food
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Men and women aged between 20 and 64 at the time of obtaining consent (2) Persons who can consume one serving of the test food per day (3) Persons who can receive the test food once a week (4) Those who defecate between three and five times a week (5) Persons who have been fully informed about the test, understand its content and are able to give their written consent
Exclusion criteria
Exclusion criteria: (1) Persons who consume foods for specified health uses, functional foods, health foods, yoghurt or probiotic drinks at least three times a week, which may affect the test (2) Persons who have taken, or plan to take during the study period, any medication that will affect the study one month prior to the pre-test (3) Persons with a history of appendectomy (4) Persons who have undergone surgery within six months from the time consent was obtained that may have affected the study (5) Heavy alcohol drinkers (6) Persons whose roommates are planning to participate in the same study (7) Persons with extremely irregular eating habits (8) Persons who had one or less meals per day at least once a week during the month prior to application for the trial (9) Persons who plan to change their existing lifestyle, eating habits or living environment during the trial period (10) Those currently participating in a clinical trial of another medicine or health food product and plan to participate in another clinical trial within 4 weeks of the completion of the trial, or after consent to participate in the trial (11) Persons with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc. (12) Pregnant, lactating or intending to become pregnant during the study period (13) Persons with allergies to medicinal products or food (especially wheat, egg and milk) (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) Persons who are deemed by the study investigator or sub-investigator to be unsuitable to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Short-chain fatty acids content in fecal samples taken at the time of 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| - Intestinal microbiota - Intestinal metabolites - Defecation status (days of defecation, frequency of defecation, volume of stool, stool consistency, stool color, feeling of residual stool during defecation, abdominal pain during defecation, odor) - Blood microRNA - Clinical laboratory values - Alteration in clinical laboratory values - Adverse event/Side effect | — |
Countries
Japan
Contacts
Public ContactFumiko Nakamura
CPCC Company Limited Clinical Support Division
Outcome results
None listed