Healthy Japanese
Conditions
Interventions
Duration: 12 weeks The test food
Duration: 12 weeks Placebo
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals who defecate three to five times in Period 1 6. Individuals whose BMI is 23 kg/m2 or more and less than 30 kg/m2 7. Individuals who are classified as "Hidden Obese" or "Obese" in the body composition measurement at Scr
Exclusion criteria
Exclusion criteria: Individuals 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 medications (including herbal medicines) and supplements 6. are allergic to medicines and foods related to the test product 7. are pregnant, lactating, or planning to become pregnant during this study 8. have chronic constipation or diarrhea 9. have had diarrhea for at least 2 weeks prior to agreeing to participate 10. meet the diagnostic criteria for irritable bowel syndrome (IBS) or have already been diagnosed with IBS 11. have other diseases that may significantly affect bowel movement 12. usually take foods containing rich in lactic acid bacteria, or health foods or medicines fortified with lactic acid bacteria 13. usually take medicines, health foods, "Foods for Specified Health Uses," or "Foods with Functional Claims," that may affect bowel movement / take foods fortified with ingredients affecting bowel movement (e.g., fermented foods such as natto, kimchi, and pickles and foods fortified with dietary fiber) 14. 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 15. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of the visceral fat area at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of the total fat area and the subcutaneous fat area at 12w 2. The measured values of the defecation frequency, the numbers of defecation days, and the amount of defecation in period 2~13* *Period 2~13: Periods separated by 7 days from the start of intervention 3. Individuals whose stool shape, stool smell, and exhilarating feeling of defecation improved by one or more scales in period 2~13 compared to period 1* *Period 1: 7 days prior to screening (before intervention; Scr) 4. The score of the Constipation Assessment Scale (CAS) at 12w 5. Individuals whose responses to each item in the CAS Middle Term version (CAS-MT) improved by one or more scales at 12w compared to Scr 6. The measured values of the occupancy rate of bacteria in the stool and the alpha diversity index at 12w 7. The measured values of the body weight, body fat percentage, and waist circumference at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed