A verification study for the improvement of brain fatigue

Not Applicable

• Conditions: Healthy Japanese subjects

• Registration Number: JPRN-UMIN000043492
• Lead Sponsor: ORTHOMEDICO Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-02
• Study Completion: 2021-06-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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