Healthy volunteers
Conditions
Interventions
Subjects consume two pieces of food believed to improve the enteral environment daily for 12 weeks.
Subjects consume two pieces of a placebo food daily for 12 weeks.
Sponsors
Kochi University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Those who receive an appropriate explanation of the purpose and content of the study, are able to consent, voluntarily request to participate after gaining a full understanding, and are able to consent to participation in this survey in writing. 2. Healthy individuals with a defecation frequency of 2 to 5 times per week, inclusive.
Exclusion criteria
Exclusion criteria: Individuals meeting any of the following conditions will not be selected as study subjects: 1. Pregnant and nursing mothers, and individuals with a desire to become pregnant during the study period 2. Individuals taking medication on a routine basis 3. Individuals who are taking foods for specific health use, foods with function claims, and/or health foods, in the case that such foods affect gastrointestinal function 4. Individuals with persistent diarrhea. 5. Individuals with a fruit allergy 6. Individuals whose fasting blood test results during a physical examination include: blood glucose >=126 mg/dL, LDL cholesterol >=140 mg/dL, triglycerides >=150 mg/dL, or HDL cholesterol <40 mg/dL 7. Other individuals deemed unsuitable by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency, defecation quantity, stool form, stool hardness, stool color, stool odor, and post-defecation feeling | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fecal flora (Lactobacillus, Bifidobacterium) 2. Anti-metabolic syndrome effect (LDL cholesterol, triglycerides, HDL cholesterol, fasting blood sugar, insulin, HbA1c) | — |
Countries
Japan
Contacts
Public ContactShunji Mizobuchi
Kochi Medical School, Kochi University Clinical nursing
Outcome results
None listed