Effects of consumption of the test food on the intestinal environment in healthy Japanese subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000049636
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 56
Not provided
Subjects (who/whose) 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. are currently taking medications (including herbal medicines) and supplements 6. are allergic to medicines and/or the test food related products (particularly, galactooligosaccharide) 7. are pregnant, lactating, or planning to become pregnant during this trial 8. suffer from COVID-19 9. have been enrolled in other clinical trials within the last 28 days before agreeing to participate or plan to participate another trial during this trial 10. are judged as ineligible in this study by the physician 11. have lactose intolerance 12. have a medical history of autoimmune disease or sea squirt asthma 13. usually take food/beverage containing functional ingredients that may influence the intestinal environment (e.g. dietary fiber, indigestible dextrin, isomaltodextrin, inulin, guar gum degradation products, fructooligosaccharides, galactooligosaccharides, lactulose, lactic acid bacteria, bifidobacteria, butyric acid bacteria, Bacillus subtilis var. natto, maltobionic acid, fucose, cocoa polyphenols, raffinose, kestose, polydextrose, lactosucrose, xylooligosaccharide, isomaltooligosaccharide, psyllium, resistant starch, galactomannan, or glucomannan) 14. usually take fermented foods (e.g. yogurt or natto), foods with rich dietary fiber (e.g. brown rice or green juice), or foods containing oligosaccharide (e.g. banana or honey)/who take them to improve the intestinal environment 15. food intake was extremely high/low right before Scr
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method