A verification study for improving cognitive function with consumption of the test food in healthy subjects aged 40 or more: A randomized double-blind placebo-controlled trial - A verification study for improving cognitive function with consumption of the test food in healthy subjects aged 40 or more

ORTHOMEDICO Inc.0 sites24 target enrollmentJuly 20, 2021

ConditionsHealthy Japanese subjects

Overview

Phase: 未知
Intervention: Not specified
Conditions: Healthy Japanese subjects
Sponsor: ORTHOMEDICO Inc.
Enrollment: 24
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

July 20, 2021

End Date

December 19, 2021

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\.have a history or current history of serious diseases of the heart, liver, kidneys, or digestive organs, or a history of major digestive system surgery such as gastrectomy, gastrointestinal suture, or intestinal resection 2\.have a pacemaker or an implantable cardioverter defibrillator 3\.are a treatment for chronic diseases 4\.have significant abnormalities in blood pressure, physical and/or hematological data 5\.have severe anemia 6\.are pre\- or post\-menopausal women with severe physical changes 7\.have dementia 8\.have mental health issues 9\.take medications and supplements 10\.take supplements and/or foods related to improving cognitive functions, and/or take blue\-backed fish at least 4 times a week 11\.use devices, equipment, and applications that may affect cognitive functions at least 4 times a week 12\.are allergies (particularly to wheat, eggs, milk, and soy) 13\.are smoker 14\.are heavy alcohol intake 15\.with extremely irregular life rhythms 16\.are on a carbohydrate restriction or diet, or who plan diet during the test period 17\.have eaten less than one meal per day at least once a week for the past a month 18\.may change their lifestyles during the test period 19\.can't do the following actions: replace the main meal with test food at any 2 meals, receive the test food twice per week, and/or store test foods in frozen storage 20\.are pregnant, breast\-feeding, or planning to become pregnant 21\.have been enrolled in other clinical trials within the last 4 weeks (wks) before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period or within 4 wks after test period 22\.donated blood before consuming the food (whole blood either 400 mL within 16 wks \[women] or 12 wks \[men], 200 mL within 4 wks \[both], or blood components within 2 wks \[both]) 23\.are judged as ineligible to participate in the study by the physician