Examination of appetite suppression in healthy subjects by consumption of the test food
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000044608
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 11
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The measured values of body weight at 8 weeks after consumption (8w)
- Secondary Outcome Measures
Name Time Method 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