Tokyo, Oct. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000053586) titled 'Changes in muscle oxygen saturation and salivary components due to fatigue accumulated during endurance exercise' on Oct. 31.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Placebo

Primary Sponsor: Institute - EZAKI GLICO Co., Ltd.

Condition: Condition - healthy subjects Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To quantify the exercise-induced fatigue by measuring changes in biological components, muscle oxygen saturation and others during endurance exercise Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Endurance exercise over 3 days Interventions/Control_2 - Endurance exercise over 3 days

Eligibility: Age-lower limit - 18 years-old

Gender - Male Key inclusion criteria - 1) Athletes who specialize in endurance sports and continue to train for competition purposes 5-7 days per week. 2) Athletes whose workout routine includes an endurance exercise, averaged over the last three months, 1-3 days per week (at least 30 minutes per session, lasting at least 6 months). Key exclusion criteria - 1)Persons who are unable to refrain from taking health foods, quasi-drugs and over-the-counter medicines, including supplements that affect the circulatory system and metabolism taken orally, and from using topical analgesic anti-inflammatory drugs such as compresses during the period of this study. However, those who have been prescribed medicines or other drugs by a doctor or pharmacist for therapeutic purposes should ask the doctor or pharmacist for a decision on discontinuation. 2)Persons who are unable to refrain from alcohol consumption and smoking during the period of this study. 3)Those with a BMI of 25.0 kg/m^2 or more. 4)Persons with serious illnesses such as diabetes, liver disease, renal disease, cardiac disease, cardiovascular disease, etc., and persons with pre-existing such illnesses. 5)Persons with a disease undergoing treatment or with a pre-existing serious disease requiring medication. 6)Persons who are unable to refrain from exercise other than that permitted by the research during the period of this study. 7)Persons who have participated in other clinical studies within one month of obtaining consent to participate in this study, or who plan to participate in other clinical studies after obtaining consent to participate in this study. 8)Any other person who is deemed unsuitable as a subject by his/her family doctor. Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2024 Year 01 Month 25 Day Anticipated trial start date - 2024 Year 02 Month 06 Day Last follow-up date - 2024 Year 04 Month 26 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061134

Disclaimer: Curated by HT Syndication.