Effects of consumption of the test food on body fat, intestinal bacteria, and other vital data in healthy Japanese subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000049646
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 12
Not provided
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 a smoker 7. Subjects who drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 8. Subjects whose sleeping time or habit is irregular due to work such as a late-night shift 9. Subjects whose meal time is irregular 10. Subjects who are allergic to medicines and/or the test food related products (particularly, wheat, beef, pork, eggs, chicken, soy, milk ingredients, sesame, mackerel, shrimp, almonds, bananas, cashew nuts, walnuts, salmon, peach, or Japanese yam) 11. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 12. Subjects who suffer from COVID-19 13. 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 14. Subjects who are judged as ineligible to participate in this study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Body mass index (BMI) at eight weeks after consumption (8w)
- Secondary Outcome Measures
Name Time Method 1. Body weight, body fat percentage, fat mass, lean body mass, muscle mass, diversity of intestinal bacteria, list of all bacteria species, share ratio of major bacteria, and f/b values at 8w 2. Body weight, BMI, body fat percentage, visceral fat percentage, basal metabolic rate, and body age between one week after consumption and 8w