Healthy Japanese
Conditions
Interventions
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Duration>
Period I: Active food Period II: Placebo food *The intervention sequence is Period I to Period II. *Washout period is for one week and more.
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Period I: Placebo food Period II: Active food * The intervention sequence is Period I to Period II. *Washout period is for one week and more.
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. Individuals aged 20 or more and less than 60 4. Healthy individuals
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who use or take "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines and/or the test food related products (particularly, eggs, milk ingredients, almond, soy, or gelatin) 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 9. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The feeling of satiety measured by visual analog scale (VAS) before and 30, 60, 90, 120, 180, and 240 minutes after consumption of the test food | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The subjective symptoms (satisfaction, hunger, appetite, energy, vitality, concentration, motivation, mood, and irritation) measured by VAS before and 30, 60, 90, 120, 180, and 240 minutes after consumption of the test food 2. The blood glucagon-like peptide 1 (GLP-1) level before and 30, 60, 90, 120, 180, and 240 minutes after consumption of the test food 3. The incremental area under the curve (IAUC) and the maximum blood concentration (Cmax) of the blood GLP-1 level | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed