Effects of consumption of the test food on appetite in healthy Japanese subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000049108
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 46
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 allergic to medicines and/or the test food related products 7. Subjects whose score of the Council of Nutrition Appetite Questionnaire (CNAQ-J) is 16 or less 8. Subjects whose BMI has increased or decreased by 10% or more within the last three months 9. Subjects who work in the late-night shift or in shifts at least once weekly 10. Subjects who work with driving vehicles or operating machinery accompany by danger 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. The feeling of hunger and prospective food consumption measured by visual analogue scale (VAS) at two weeks after consumption (2w) 2. The feeling of hunger and prospective food consumption measured by VAS at pre-consumption examination (single ingestion; 0w)
- Secondary Outcome Measures
Name Time Method 1. Appetite survey 2. The subjective diet-related quality of life (SDQOL) 3. MOS Short-Form 36-Item Health. Survey (SF-36v2) 4. Blood markers 5. Body composition 6. Nutrition survey