Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing plant extract Administration: Take three capsules once per day with water immediately before snack or dinner. *If you forget to take the test
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese healthy subjects aged 20 or over to under 65 years old 2. Subjects who have the habit of snacking (i.e., the habit of consuming fructose-containing foods) 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects whose fructose intakes are relatively high in the dietary survey during the last three days before screening (before consumption; Scr) 5. Subjects whose values of BMI are 23 kg/m2 or more and less than 30 kg/m2 at Scr 6. Subjects who receive a full explanation of the procedures in the study, understand the explanation, and provide informed consent signed by themselves 7. Among the subjects who met the inclusion criteria, select 198 of them as the combination of the subjects with the minimum standard deviation of the visceral fat area at Scr
Exclusion criteria
Exclusion criteria: Subjects (who) 1.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.undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4.take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 5.take herb or supplements with hypoglycemic effects in daily use 6.planning to undergo a surgical operation during the intervention period or within two weeks from the date of finish of the intervention period 7.taking medicines (include herbal medicines) and supplements 8.allergic to medications and/or the test-food-related products 9.have weak stomach and may feel discomfort such as convergence in the stomach, particularly when taking beverages containing tannin such as strong green tea, black tea, or coffee 10.pregnant, lactation, or planning to become pregnant 11.have unhealthy eating habits or irregular rhythm of life 12.drink an excess of alcohol *weekly average of alcohol intake is more than 60 g/day [Reference materials for the promotion of Health Japan 21 (the second term)] 13.have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 14.have donated blood component or 200-mL whole blood within the last one month before the agreement to participate in this trial 15.have donated 400-mL whole blood within the last three month before the agreement to participate in this trial 16.are scheduling to have a total of more than 1,200 mL of blood drawn until the end of this study from the 12 months before the date of consent obtained 17.judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The visceral fat area at 12 weeks after the start of the test-food consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The visceral fat area at eight weeks after the start of test-food consumption (8w) 2. The subcutaneous fat area, total fat area, body weight, body mass index (BMI), abdominal circumference, waist circumference, body fat percentage, fat mass, lean body mass, and muscle mass at 8w and 12w 3. The serum levels of total cholesterol (T-Ch), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), and triglyceride (TG) 4. Each item of the questionnaire at 4w, 8w, and 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed