Healthy Japanese
Conditions
Interventions
Duration: Four weeks Test product: Collagen peptides (fish-derived) Administration: Dissolve 10 packets (5 g/packet, a total of 50 g/day) in water, warm water, beverages such as coffee, or meal such
Sponsors
Nippi, Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are 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 are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who take protein or collagen-rich foods (such as protein drinks, protein bars, protein powders, or collagen powders) at least two days (two servings) a week 6. Individuals who are on restricted diets, such as carbohydrate restriction diet or vegetarian diet 7. Individuals who are taking or using medications (including herbal medicines) or supplements 8. Individuals who are allergic to medicines and foods related to the test product (particularly fish, type I collagen, or gelatin) 9. Individuals who are pregnant, lactating, or planning to become pregnant during this study 10. 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 in another study during this study 11. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Individuals who experienced adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Individuals whose values of urinalysis and blood test are outside the reference range after intervention despite within the reference range at screening | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed