Male/female adults
Conditions
Interventions
Consumption of the test food (one a day) for 4 weeks
Consumption of the placebo food (one a day) for 4 weeks
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 20 to 64 years old. 2. Subjects who defecate less than and equal to 5 times in a week. 3. Subjects who consume wheat flour products such as bread and noodles at least 4 days a week. 4. Subjects who can receive the test food once a week. 5. Subjects who can consume one test food per day. 6. Subjects who can give informed consent to partake in this research, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: 1. Subjects who take steadily (not less than 2 times a week) in the Food for Specified Health Uses (FOSHU), Foods with Function Claims, health food or supplementary food which might affect the intestinal environment. * However, subjects who consume the above-mentioned food products once a week or less, but cannot discontinue them from the time of obtaining consent, are not eligible to participate. 2. Subjects who consume yogurt, lactic acid bacteria beverages, and high-fiber staple foods (such as brown rice, barley, whole wheat bread, cereals, and foods with nutrient fortification claims) that are not classified as Food for Specified Health Uses (FOSHU) or Foods with Function Claims, three or more times a week. 3. Subjects who have had one or more days per week with less than one meal per day in the month leading up to the preliminary examination. 4. Subjects who are on a carbohydrate-restricted diet or are dieting. 5. Subjects with excessive alcohol intake. 6. Subjects with extremely irregular lifestyles (such as night shifts, irregular shift work, etc.). 7. Subjects with a BMI of 30.0 kg/m2 or above. 8. Subjects who plan to change their lifestyle, dietary habits, or living environment (such as moving or job transfer) during the trial period. 9. Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. 10 Subjects who have a cohabitant planning to participate in this trial. 11. Subjects with a history of appendectomy. 12. Subjects who have undergone surgery that is considered to affect the trial within six months prior to obtaining consent (e.g., colonoscopic surgery, gallstone/gallbladder removal, gastric bypass surgery, etc.). 13. Subjects who have taken medications affecting the intestinal environment (such as antibiotics, probiotics, laxatives, etc.) one month prior to Week 0 of Phase 1, or who plan to do so during the trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of defecations | — |
Secondary
| Measure | Time frame |
|---|---|
| Total amount of short-chain fatty acids in feces (sum of acetic acid, propionic acid, and n-butyric acid) Short chain fatty acids in feces (acetic acid, propionic acid, and n-butyric acid) Organic acid in feces (lactic acid, succinic acid, iso-valeric acid, n-valeric acid, formic acid, iso-butyric acid) Ammonia in feces Fecal putrefactive products (phenol, p-cresol, 4-ethylphenol, skatole, indole) Water in feces pH in feces Defecation status (the number of days, frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor) CAS-MT Visual Analog Scale (stress, fatigue, the feeling at waking up this morning, concentration) Gut microbiota | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed