Healthy Japanese subjects
Conditions
Interventions
Duration: 8 weeks Test food: Food containing basil seed Administration: Take 2 g twice per day within 1 hour before lunch and dinner. Add about 150 mL of water into 1 packet (2 g), stir well and al
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. Subjects aged 20 years old or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects whose BMI are between 25 kg/m2 or more and less than 30 kg/m2 at screening (Scr) 7. For subjects whose body weight are relatively heavy at Scr, taking account of the value of body fat percentage and the VAS score (satiety)
Exclusion criteria
Exclusion criteria: 1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who are currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 4. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 5. Subjects who are currently taking medications (including herbal medicines) and supplements, particularly taking antihypertensive drugs, anticoagulants and antiplatelet drugs in daily 6. Subjects who are allergic to medicines and/or the test food related products, particularly basil 7. Subjects who are scheduled for surgery during the consumption or within 2 weeks after the end of consumption 8. Subjects who are pregnant, breast-feeding, or planning to become pregnant after the agreement to participate in this trial 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 the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured values of body weight at 8 weeks after consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| The measured values of the visual analogue scale (VAS) score (satiety, hunger, fullness, desire to eat richly flavored food, constipation, feeling refreshed during defecation, lightness of body, skin moisture, skin dullness, skin firmness and elasticity), nutrition-related items {weight, energy, moisture, protein, amino acid composition protein, fat, triglyceride (TG) equivalents, saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids, cholesterol, carbohydrates, available carbohydrates (monosaccharide equivalents), soluble dietary fiber, insoluble dietary fiber, total dietary fiber}, body mass index (BMI) and body fat percentage at 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed