Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Tablet containing garlic extract Administration: Take two tablets within 30 minutes after breakfast. * Daily dose should be taken within the day. If you forget to
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. Male or female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects who have a relatively big difference in VAS of fatigue between before and after the fatigue load
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or 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 disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 5. Subjects who take supplements related to improving cognitive functions, such as garlic extract, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, astaxanthin, and gamma-aminobutyric acid (GABA) in daily 6. Subjects who use tools, games, devices, and application related to improving cognitive functions such as Shogi, Go, and puzzle or game of brain training in daily 7. Subjects currently taking medicines (include herbal medicines) and supplements 8. Subjects who are allergic to medicines and/or the test food related products 9. Subjects who are pregnant, breast-feeding, and planning to become pregnant 10. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 11. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of Visual Analogue Scale (VAS) of fatigue at before and after the fatigue load of four weeks after the start of test food consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of VAS of fatigue at before and after the fatigue load of two weeks after the start of test food consumption (2w) 2. The amount of changes of VAS of fatigue at before and after the fatigue load from screening (before consumption; Scr) to 2w and four weeks after the start of test food consumption (4w) 3. The measured values of VAS of fatigue at before the fatigue load and after the fatigue load at 2w and 4w, and the amount of changes from Scr to 2w and 4w 4. The measured values of standardized score in each cognitive domain by Cognitrax at 2w and 4w, and the amount of changes from Scr to 2w and 4w 5. The measured values of flicker value (average of both eyes, dominant eye, and non-dominant eye), and VAS {sharp mind, concentration, thinking ability, brain (mental) fatigue, motivation (commitment), stress, frustration, stiff shoulder (fatigue in the shoulders), malaise (languor), and eye fatigue} at before, after, and before and after the fatigue load at 2w and 4w, and the amount of changes from Scr to 2w and 4w 6. The measured values of "My head doesn't feel clear when I wake up from sleep," "My head doesn't feel clear in the evening," "My sleep quality is not good," "I am concerned about my body odor," and "I am concerned about odor in my mouth" at 2w and 4w * The value of "before and after the fatigue load" is defined as value subtracted after the fatigue load from before the fatigue load. | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed