Healthy volunteer
Conditions
Interventions
Intake of active food for 4 weeks
Intake of placebo food for 4 weeks
Sponsors
MEGMILK SNOW BRAND Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy males and females aged 20-64 years at the time of consent to participate in the study. 2)Individuals with 3 to 5 bowel movements per week during the run-in period. 3)Individuals who can visit the trial site on the scheduled visit dates, and who can collect and submit fecal samples within the specified period. 4)Individuals who understand the purpose and content of the study and provide online informed consent prior to participation.
Exclusion criteria
Exclusion criteria: 1)Individuals who regulary take medicines/foods that affect the intestinal environment. 2)Individuals with a history of serious liver, kidney, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease. 3)Individuals with chronic diseases and who regularly use medicines. 4)Individuals with a current or history of drug or alcohol dependence. 5)Individuals with a history of gastrointestinal disease or surgery that affects digestion, absorption, or defecation. 6)Individuals with food allergies related to the test food. 7)Individuals with extremely irregular dailyand eating habits (including late-night workers). 8)Individuals who cannot restrict the use of drugs/foods that affect the study after providing informed consent. 9)Individuals with excessive exercise, drinking and smoking habits. 10)Pregnant or lactating women, or women who may become pregnant during the study period. 11)Individuals who have taken antibiotics within 1 month prior to providing informed consent or who will take antibiotics during the study period. 12)Individuals who have participated in, are currently participating in, or plan to participate in any other clinical research within 1 month prior to providing informed consent or during the study period. 13)Individuals who plan to change their lifestyle drastically after providing informed consent and before the end of the study. 14)Individuals who plan to travel abroad after providing informed consent and before the end of the study. 15)Individuals who are judged to be unsuitable based on their responses to the background questionnaire. 16)Other individuals who are judged by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of defecations per week | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation survey Fecal organic acid concentrations | — |
Countries
Japan
Contacts
Public ContactToyotada Ashino
Trans Genic Inc. Clinical Research Department
Outcome results
None listed