Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: 100calatt (frozen ready-made side dish) Administration: For five days per week, replace any one of your regular daily meals with the test food. * For two days whe
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Women 3. Subjects aged 30 or more and less than 60 4. Healthy subjects 5. Subjects who can store and consume the test food as the prescribed method 6. Subjects with a height of 150 cm or more and less than 175 cm 7. Subjects with a body weight of 50 kg or more and less than 90 kg 8. Subjects with a BMI of 23 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Body mass index (BMI) at eight weeks after consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed