MedPath

Examination of the Effects and Safety of a Test Food Ingestion on Knee Pain and Motility Function: A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study

Not Applicable
Conditions
/A(healthy adults)
Registration Number
JPRN-UMIN000035251
Lead Sponsor
TES Holding Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
70
Inclusion Criteria

Not provided

Exclusion Criteria

[1]Individuals using medical products. [2]Individuals receiving outpatient care (except for bonesetters, chiropractors, massagers) for knee and/or low back pain. [3]Individuals who are a patient or have a history of rheumatic disease. [4]Individuals whose grade of Kellgren-Lawrence grading system is over Grade II. [5]Individuals with history of palliative therapy (hyaluronic acid, steroid injection, etc.) or surgical therapy (arthroscopic osteotomy, artificial joint, bolt fixation surgery, etc.)on knees and/or waist. [6]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders. [7]Individuals who are a patient or have a history of receiving medical drug treatment for the past 1 month (except for temporary relief medication for headache, menstrual pain, common cold). [8]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [9]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [10]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [11]Individuals with serious anemia. [12]Individuals who are sensitive to test product or other foods, and medical products. [13]Individuals having a habit to intake a food containing the component of the test food. [14]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [15]Individuals who may significantly change exercise habit or lifestyle during the study period. [16]Individuals who are or are possibly, or are lactating. [17]Individuals who participated in other clinical studies in the past 3 months. [18]Individual with potential conflict of interests. [19]Individuals judged inappropriate for the study by the principal.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath