Tokyo, Nov. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059738) titled 'Study on the Effects of Test Food Intake on Shoulder Discomfort, Shoulder Load, Scapular Range of Motion, and Shoulder Blood Flow - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Trial -' on Nov. 11.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - TES Holdings Co., Ltd.

Condition: Condition - No Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the effects of continuous consumption of the test food on shoulder function assessment and to examine its safety. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Oral ingestion of a test food (3 tablets in a day; 8 weeks). Interventions/Control_2 - Oral ingestion of a placebo food (3 tablets in a day; 8 weeks).

Eligibility: Age-lower limit - 30 years-old

Gender - Male and Female Key inclusion criteria - 1) Males and females aged 30 years or older but under 65 years at the time of obtaining consent to participate in the trial. 2) Individuals in good health with no chronic physical conditions. 3) Individuals who frequently experience shoulder strain or stiffness in daily life. 4) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this trial. 5) Individuals who can attend the designated examination date and undergo the examination. 6) Individuals deemed suitable for participation in this trial by the principal investigator. Key exclusion criteria - 1) Individuals using medical products. 2) Individuals suffering from shoulder joint disorders or similar conditions. 3) Individuals with a history or current condition of serious impairment affecting the eyes, digestive organs, liver, kidneys, heart, lungs, blood, or mental health. 4) Individuals who used a drug to treat a disease in the past 1 month. 5) Individuals whose BMI is over 30 kg/m2. 6) Individuals with drug and food allergies. 7) Individuals who currently have, or have had within the past three months, a habit of regularly consuming functional foods, health foods, or supplements that claim to improve blood flow or reduce fatigue, or that contain ingredients that could potentially affect test results; as well as individuals who plan to consume such products during the test period. 8) Individuals whose average weekly pure alcohol consumption exceeds 40 g/day for men and 20 g/day for women. 9) Individuals with possible changes of life style during the test period. 10) Individuals engaged in shift work or night work involving regular fluctuations in working hours. 11) Individuals who have a smoking habit. 12) Individuals who are or are possibly pregnant, or are lactating. 13) Individuals unable to restrict the use of massage, osteopathy, chiropractic, acupuncture, or the application of heat packs and hot compresses during exam periods. 14) Individuals who participated in other clinical studies in the past 3 months. 15) Individuals who are or whose family is engaged in healthy or functional foods. 16) Individuals who are unable to follow instructions from the study supervisor or who judged inappropriate for the study by the principal. Target Size - 48

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 28 Day Date of IRB - 2025 Year 10 Month 30 Day Anticipated trial start date - 2025 Year 12 Month 24 Day Last follow-up date - 2026 Year 03 Month 19 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068220

Disclaimer: Curated by HT Syndication.