Effects of consumption of the test food on cognitive function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on cognitive function in healthy Japanese

ORTHOMEDICO Inc.0 sites68 target enrollmentDecember 6, 2023

ConditionsHealthy Japanese

Overview

Phase: 未知
Intervention: Not specified
Conditions: Healthy Japanese
Sponsor: ORTHOMEDICO Inc.
Enrollment: 68
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

December 6, 2023

End Date

April 26, 2024

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

ORTHOMEDICO Inc.

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Individuals 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 3\. are currently undergoing treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, autoimmune disease, hemorrhagic disease, or any other chronic diseases 4\. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5\. are taking medications, herbal medicines, or supplements 6\. are allergic to medicines and/or the test food related products 7\. are pregnant, lactating, or planning to become pregnant during the study 8\. have been enrolled in other clinical studies within 28 days before agreeing to participate or plan to participate another study during the study 9\. have dementia 10\. have a medical history of mental disorder (e.g., depression disorder, attention deficit/hyperactivity disorder) 11\. usually take procyanidins\-rich foods (e.g., apple, black soybean, cacao) 12\. usually take foods or supplements that may affect cognitive functions (e.g., DHA, EPA, ginkgo leaf extract, tocotrienol, astaxanthin, GABA, phosphatidylserine, plasmalogen) 13\. take blue\-backed fish (e.g., sardines, mackerel, saury) at least 4 times a week 14\. use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles or games) 15\. have irregular sleeping time or habit due to night shift or other reasons 16\. are smokers or have quit smoking within 3 months before agreeing to participate 17\. usually drink more than 60 g/day of alcohol 18\. have irregular lifestyles (e.g., diet, exercise, sleep) 19\. have pollen allergy 20\. may undergo surgery (including tooth extraction, endoscopic examination, or others) during the study or within 4 weeks after the end of consumption 21\. are judged as ineligible to participate by the physician