Healthy Japanese subjects
Conditions
Interventions
Duration: Two weeks Take one active tablet with a drink such as water once daily. *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day a
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. Adults aged 40 or more 4. Healthy subjects 5. Subjects whose the feeling of hunger measured by VAS is relatively low 6. Subjects whose BMI is 18.5 kg/m2 or more and less than 25 kg/m2 7. Subjects who have given written informed consent to participate in this trial 8. Subjects who do not have an exercise habit
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed