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

ORTHOMEDICO Inc.0 sites40 target enrollmentAugust 2, 2021

ConditionsHealthy Japanese subjects

Overview

Phase: 未知
Intervention: Not specified
Conditions: Healthy Japanese subjects
Sponsor: ORTHOMEDICO Inc.
Enrollment: 40
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

August 2, 2021

End Date

January 23, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

ORTHOMEDICO Inc.

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Subjects who 1\. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2\. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3\. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4\. have dementia 5\. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 6\. are smoker at the time of the agreement to participate in this trial or plan to smoke during this trial 7\. plan to have surgery from first consumption to two weeks after last consumption 8\. take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage at least four times a week 9\. take supplements related to improving cognitive functions, such as docosahexaenoic acid, eicosapentaenoic acid, ginkgo leaf extract, tocotrienol, astaxanthin, gamma\-aminobutyric acid, phosphatidylserine, and plasmalogen at least four times a week 10\. take blue\-backed fish such as sardines, mackerel, and saury at least four times a week 11\. use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) in daily 12\. are currently taking medications (including herbal medicines) and supplements 13\. are allergic to medications and/or the test\-food\-related products (particularly citrus fruit) 14\. are pregnant, lactation, or planning to become pregnant 15\. 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 16\. are judged as ineligible to participate in the study by the physician