A verification study for improving cognitive function with consumption of the test food in healthy subjects: A randomized double-blind placebo-controlled trial - A verification study for improving cognitive function with consumption of the test food in healthy subjects

ORTHOMEDICO Inc.0 sites66 target enrollmentNovember 16, 2020

ConditionsHealthy Japanese subjects

Overview

Phase: 未知
Intervention: Not specified
Conditions: Healthy Japanese subjects
Sponsor: ORTHOMEDICO Inc.
Enrollment: 66
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 16, 2020

End Date

May 29, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

ORTHOMEDICO Inc.

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction 2\. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3\. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 4\. Subjects who have dementia 5\. Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 6\. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 7\. Subjects who take supplements related to improving cognitive functions, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma\-aminobutyric acid (GABA), phosphatidylserine, and plasmalogen in daily use 8\. Subjects who regularly take blue\-backed fish such as sardines, mackerel, and saury 9\. Subjects who regularly use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) 10\. Currently taking medicines (include herbal medicines) and supplements 11\. Subjects who are allergic to medicines and/or the test food related products, especially to salmon, milk, or soy 12\. Subjects who are pregnant, breast\-feeding, or planning to become pregnant 13\. 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 enroll in another clinical trial during trial period 14\. Subjects who are judged as ineligible to participate in the study by the physician