None
Conditions
Interventions
Oral intake of test food (4 weeks)
Sponsors
APO PLUS STATION CO., LTD.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy Japanese males whose age is between 20 and 60 years old. 2) No gastrointestinal disease. 2) No gastrointestinal disease, and not taking any medication during treatment. 3) BMI between 20 kg/m2 and 30 kg/m2. 4) Subjects who are aware that their intestinal environment is not good, such as constipation. 5) The subjects must have received a full explanation of the purpose and content of the study and must have signed a consent form prior to the start of the study.
Exclusion criteria
Exclusion criteria: 1) Those with a history or current condition (disease) of liver disease, renal disease, cerebrovascular disease, diabetes, dyslipidemia, hypertension, or other chronic disease 2) Persons who are currently undergoing treatment for a serious illness. 3) Persons with food allergies or those who are at risk of developing allergies related to the tested food 4) Who are regularly using medicines or quasi-drugs that may affect the test items. 5) Persons who regularly use health foods (food for specified health use, nutritional supplements, functional foods, supplements, etc.) that may affect the test items. 6) Persons who are unable to discontinue the intake of pharmaceuticals (excluding intravenous medication), quasi-drugs, or health foods (food for specified health uses, nutritional supplements, foods with functional claims, supplements, etc.) from the time of obtaining consent to the completion of the study. 7) Persons who are unable to restrict or discontinue foods (including alcohol) that affect the data 8) Who are currently participating in a clinical trial or have participated in another clinical trial within the past 3 months from the date of obtaining consent 9) Who plan to participate in other clinical trials during the study period 10) Who are unable to maintain their daily lifestyle. 11) Who have difficulty consuming the study food as directed 12) Other subjects who are judged by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bifidobacteria, good bacteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Other intestinal environment data | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactMasako Mizuuchi
APO PLUS STATION CO., LTD. Clinical Operations Department, CRO Division
Outcome results
None listed