Healthy adult
Conditions
Interventions
Intake of test foods (1 capsule per day) for 4 weeks
Intake of placebo food (1 capsule per day) for 4 weeks
Sponsors
Kagoshima Immaculate Heart University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy adult males and females between 18 to 65 years (2) BMI: less than 30 kg/m2 (3) Subjects who have a tendency toward constipation (4) Subjects who have received sufficient explanation about the purpose and content of the examination, have the ability to consent, have a good understanding, volunteered to participate and agreed to participate in the examination in writing
Exclusion criteria
Exclusion criteria: 1. Subjects who were diagnosed with liver, kidney, gastrointestinal, heart, diabetes, or other diseases that may affect the results of this study, or who have a history of surgery 2. Subjects with a disease currently under treatment 3. Subjects who detect abnormal values by blood test 4. Subjects who determine ineligible by principal investigator 5. Subjects with drug or food allergies 6. Subjects who play high intensity sports and/or are on a diet 7. Subjects who can't stop using supplement, functional foods (including Food for Specified Health Uses or Foods with Function Claims), and/or Specified quasi-drugs during the current study periods 8. Subjects who are unable to stop taking "products that clearly state that lactic acid bacteria are an ingredient," excluding the test food of this study, from the time of obtaining consent, or who plan to take such products during the study period (this refers to products that clearly state that lactic acid bacteria are an ingredient, excluding those that are included in foods as a result of the manufacturing process.) 9. Subjects who are under treatment with medications 10. Those who have taken medicines that may affect the study within one month prior to the pre-test, or those who plan to take such medicines during the study period 11. Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement 12. Subjects with smoking habit 13. Subjects with irregular life patterns and lifestyle of reversal of day and night 14. Subjects who have a habit of excessive eating and drinking 15. Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period 16. Subjects who is participating in the other study or planning to participate during the study period 17. Subjects who has taken the blood sampling more than 200 mL within 1 month, or plan the blood sampling during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of bowel function (intestinal flora, fecal organic acids, fecal putrefactive products) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Evaluation of bowel function (defecation questionnaire (defecation frequency, number of defecation days, fecal output, stool consistency, stool color, stool color, post-defecation-feeling)) -Safety evaluation (blood biochemistry, hematology, adverse events) | — |
Countries
Japan
Contacts
Public ContactTakayuki Nakano
Kagoshima Immaculate Heart University Department of Nursing and Nutrition
Outcome results
None listed