A verification study of the improving effect of consumption of the test food on the immune function: a randomized, placebo-controlled, double-blind, parallel-group comparison study - A verification study of the improving effect of consumption of the test food on the immune function

ORTHOMEDICO Inc.0 sites22 target enrollmentNovember 27, 2023

ConditionsHealthy Japanese

Overview

Phase: 未知
Intervention: Not specified
Conditions: Healthy Japanese
Sponsor: ORTHOMEDICO Inc.
Enrollment: 22
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 27, 2023

End Date

February 18, 2024

Last Updated

last year

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 any of the following chronic diseases such as cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension 4\. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5\. are taking medications (including herbal medicines) and supplements 6\. are allergic to medicines and/or the test food related products 7\. take the test food or similar foods 8\. are pregnant, lactating, or planning to become pregnant during this study 9\. have been enrolled in other clinical studies within the last 28 days before agreeing to participate or plan to participate another study during this study 10\. have received vaccination for influenza or COVID\-19 within the last three months before agreeing to participate 11\. have pollen allergy such as Japanese red\-cedar or cypress, or perennial allergic rhinitis 12\. take foods which may affect the immune function such as mushroom, lactic acid bacteria, or Korean ginseng 13\. have chronic fatigue syndrome, diagnosed a doctor based on persistent fatigue lasting for six months. 14\. are smokers or have quit smoking within the last year before the agreement to participate 15\. plan to have surgery within two weeks after the last consumption 16\. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 17\. have irregular sleeping time or habit due to work such as a late\-night shift 18\. have irregular lifestyles (such as diet, exercise, and sleep) 19\. are undergoing medical treatment for menopausal syndrome 20\. work in physical labor such as transportation of heavy objects 21\. are judged as ineligible to participate by the physician