Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing animal fat Administration: Take four capsules with water after dinner *If you forget to take the test food, take it as soon as you remember. Daily
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. Subjects aged 40 or more 4. Healthy subjects 5. Subjects whose number of times of standing up from the chair is relatively few
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 who are pregnant, lactating, or planning to become pregnant during this trial 8. Subjects who suffer from COVID-19 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 this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The number of times of standing up from the chair at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total score and each item in the 25-question geriatric locomotive function scale at 12w 2. Two-step value at 12w 3. Subjective symptoms measured by visual analogue scale (VAS) at 12w 4. "Sleepiness on rising," "Initiation and maintenance of sleep," "frequent dreaming," "refreshing," "sleep length," and each item in the OSA sleep inventory MA version at 12w 5. Grip strength (right hand, left hand, and both hands average), body weight, body mass index (BMI), body fat percentage, fat mass, lean body mass, muscle mass, body water, systolic blood pressure, diastolic blood pressure, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglyceride (TG) at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed