Healthy adult
Conditions
Interventions
Take one bag of the test food once a day for 4 weeks.
Take one bag of the placebo once a day for 4 weeks.
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Men and women between 20 and 64 years of age. (2) Healthy persons who defecated 6 or more times per week during the previous observation period and had diarrhea or soft stools (Bristol stool scale 6 or 7) less than once per week (24 persons) (3) Persons prone to constipation who defecated 3-5 times a week in the previous observation period and had diarrhea or soft stools (Bristol stool scale 6 and 7) less than once a week (12 persons) (4) Those who defecated more than 3 times a week and had diarrhea or soft stool (Bristol stool scale 6 or 7) more than once a week in the previous observation period (12 persons)
Exclusion criteria
Exclusion criteria: (1) Those who regularly use foods (including foods for specified health uses) that contain a lot of dietary fiber materials (indigestible dextrin, polydextrose, indigestible glucan, etc.) (2) Those who regularly use medicines, health foods, foods for specified health uses, or functional foods that may affect bowel movements. (3) Those who are in the habit of consuming a large amount of foods that are thought to affect bowel movements (foods rich in dietary fiber and lactic acid bacteria) (4) Persons who are visiting a hospital and using medication for a bowel movement-related disease or who are regularly using over-the-counter laxatives at the time of research participation. (5) Those with a history or current condition of drug or alcohol dependence. (6) Persons with serious diseases such as diabetes, liver disease, renal disease, cardiac disease, or those with pre-existing diseases. (7) Persons at risk of developing allergies related to the research. (8) Those with a disease under treatment or with a history of serious disease that required medication. (9) Persons whose anthropometric, physical, and clinical values are significantly out of the reference range before the start of intake. (10) Those who have participated in other clinical research within one month prior to obtaining consent to participate in this study, or those who plan to participate in other clinical research after obtaining consent to participate in this. (11) Those who are pregnant or plan to become pregnant or breastfeed during the study period. (12) Those who are judged to be unsuitable as subjects based on the answers to the lifestyle questionnaire. (13) Any other person who is judged as inappropriate as a subject by the Chief Medical Officer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematologic test Blood biochemistry test Urine analysis Blood pressure/pulsation Weight/body mass index Bowel movement status (frequency of bowel movements, number of days of bowel movements, volume of bowel movements, stool characteristics) Adverse event Evaluate at points of 2 week and 4 week of intake and 2 weeks after the end of ingestion period | — |
Countries
Japan
Contacts
Public ContactShingo Yamamichi
EP Mediate Co., Ltd. Development Business Headquarters, TTC Center, Trial Planning Department
Outcome results
None listed