Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing apple polyphenol Administration: Take four capsules with water after breakfast one daily *If you forget to take the test food, take it as soon as
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 subjects 5. Subjects whose defecation frequency is three to five times per week 6. Subjects whose BMI are 25 kg/m2 or more and less than 30 kg/m2
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects 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. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products (particularly such as apple, apricot, almond, plum, peach, pear, strawberry, or birch) 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. Subjects who suffer from COVID-19 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in this study by the physician 11. Subjects who 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The defecation frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The numbers of defecation days, amount of defecation, stool shape, stool smell, and exhilarating feeling of defecation 2. The quantitative value of Akkermansia muciniphila (copies/g) 3. Body weight, body mass index (BMI), body fat percentage, fat mass, lean body mass, and muscle mass 4. Total cholesterol (T-Cho), high-density lipoprotein cholesterol (HDL-Cho), low-density lipoprotein cholesterol (LDL-Cho), LDL-Cho/HDL-Cho ratio, and triglyceride (TG) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed