Healthy Japanese
Conditions
Interventions
Duration: Four weeks Test product: Test food Administration: Three capsules/pack/day
Duration: Four weeks Test product: Placebo food Administration: Three capsules/pack/day
Sponsors
Euglena Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy participants 5. Participants with 3 to 5 bowel movements per day during any period in Screening Tests 1 and 2
Exclusion criteria
Exclusion criteria: Participants who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. are taking or using medicines (including herbal medicines) or supplements 6. regularly and intentionally consume medicines, health supplements, Foods for Specified Health Uses, Foods with Functional Claims, or foods fortified with ingredients that may affect bowel movements (e.g., fermented foods such as natto, kimchi, and pickles; foods fortified with dietary fiber; and dairy products such as yogurt, fermented milk, and cheese) 7. currently smoke or have quit smoking within one year prior to providing consent for this study 8. drink alcoholic beverages excessively 9. are on a diet or engage in strenuous exercise for the purpose of physical strengthening 10. have an irregular lifestyle due to shift work or other reasons 11. are taking anticoagulants such as warfarin 12. have extreme eating habits (e.g., strict vegetarianism, consuming only junk food, or always eating the same set menu) 13. are allergic to medicines or foods related to the test product 14. are pregnant, lactating, or planning to become pregnant during this study 15. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 16. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary defecation diary | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary defecation diary, fecal organic acid measurement, gut microbiota analysis, stool testing, and blood testing | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed