Healthy adults
Conditions
Interventions
Intake of test food, two packs a day (one pack at a time, 2 packs in total after breakfast, lunch and/or dinner) for 4 weeks.
Intake of placebo food, two packs a day (one pack at a time, 2 packs in to
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy male and female subjects ranging in age from 20 to 64 on the day of informed consent. (2) Subjects who may be low in intestinal microbiota diversity as follows: -Subjects who are aware of high intake of fats/oils and meats in their daily diet. -Subjects who are aware of low dietary fiber intake in their daily diet. (3) Subjects who give written informed consent to take part in this study after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects who take some kind of prescribed medication, including nasal/eye drops or ointments, on the day of informed consent. (2) Subjects who have regularly used and can not stop using the following products that may affect study results from the day of informed consent until the last visit; general drugs, quasi drugs, Food for Specified Health Uses, Foods with Function Claims, health foods, dietary fiber-rich products, etc. (3) Excessive alcohol intake (more than 60 g/day as pure alcohol on average). (4) Vegetarians. (5) Subjects with extremely irregular frequency or timing of meals, and/or midnight work or irregular shift work. (6) Subjects who are under the other clinical study related to medicine/food, have taken part in those studies within four weeks or be planning to participate in after informed consent. (7) Currently pregnant, intended to become pregnant or nursing an infant. (8) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (9) Subjects with previous medical history of drug and/or food allergy. (10) Subjects with weak stomach and/or diarrhea-prone constitution. (11) Subjects who donated their blood (200 mL) and/or blood components within the last one month to this study. (12) Males who donated their blood (400 mL) within the last three months to this study. (13) Females who donated their blood (400 mL) within the last four months to this study. (14) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this study. (15) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this study. (16) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal microbiota diversity index (Shannon index) after 4 weeks-intake of the test food | — |
Secondary
| Measure | Time frame |
|---|---|
| After 4 weeks-intake of the test food: -Intestinal microbiota -Fecal organic acids -Fecal putrefactive products Throughout the intake period: -Stool characteristics -Abdominal symptoms | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Sales & Planning Department
Outcome results
None listed