Male/female adults
Conditions
Interventions
Oral consumption of one test food, once daily for 14 days
Oral consumption of one placebo food, once daily for 14 days
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female aged 20 to below 65 years at the time of consent acquisition. 2. Individuals with a bowel movement frequency of five times or fewer per week. 3. Individuals who are able to receive the study food once a week. 4. Individuals able to consume one unit of the study food per day. 5. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Exclusion criteria
Exclusion criteria: 1. Individuals who consume Foods for Specified Health Uses, Foods with Function Claims, or other health foods or supplements that may affect the intestinal environment more than twice a week. Individuals who consume such products once a week or less but are unable to discontinue their use from the time of consent acquisition. 2. Individuals who consume yogurt, lactic acid bacteria drinks, or staple foods high in dietary fiber (e.g., brown rice, barley, whole-grain bread, cereals, and foods with nutritional claims that are not classified as Foods for Specified Health Uses or Foods with Function Claims) more than three times a week 3. Individuals who consume alcohol more than three times per month or who consume more than 60 g of alcohol per drinking occasion. 4. Individuals who had days with fewer than 1 meal per day more than once a week within 1 month before the preliminary examination. 5. Individuals on carbohydrate-restricted or weight-loss diets. 6. Individuals with extremely irregular lifestyles (e.g., night shift workers or those with irregular rotating shifts). 7. Individuals with a BMI of 30.0 kg/m2 or higher. 8. Individuals who plan to change their current lifestyle, dietary habits, or living environment (e.g., moving, job transfers, overseas travel or business trips) during the study period. 9. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods. 10. Individuals whose cohabiting family members are also scheduled to participate in this study. 11. Individuals with a history of appendectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bowel movement frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| Total fecal short-chain fatty acids (sum of acetic acid, propionic acid, and n-butyric acid) Fecal organic acids (acetic acid, propionic acid, n-butyric acid, iso-butyric acid, lactic acid, succinic acid, n-valeric acid, iso-valeric acid, 2-methylvaleric acid, 4-methylvaleric acid, caproic acid, malonic acid, formic acid) Moisture content in the stool Stool pH Amount of ammonia in the stool Amount of putrefactive products in the stool Gut microbiota composition Bowel movement conditions (number of days of defecation, amount of stool, stool consistency, stool color, feeling of residual stool at the time of defecation, and odor) CAS-MT (Constipation assessment scale middle term) | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed