Tokyo, Feb. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060592) titled 'Exploratory Single-Arm Nutritional Intervention Study on Condition Changes in Recreational Runners' on Feb. 5.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - EUPHORIA Co., Ltd.

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

Objective: Narrative objectives1 - To exploratorily examine the effects of a vitamin B-complex nutritional intervention on health-related condition indicators. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - nutritional supplementation

Eligibility: Age-lower limit - 18 years-old = Gender - Male Key inclusion criteria - 1.Recreational runners aged 18-49 years 2.Male 3.Individuals who have received an explanation of the study, are able to understand its content, and have provided written informed consent 4.Individuals who own a Garmin smartwatch Key exclusion criteria - 1.Individuals who are unable to abstain from smoking. 2.Individuals with a Body Mass Index (BMI) of 30.0 $kg/m^2$ or higher. 3.Individuals with serious diseases (such as diabetes, liver disease, kidney disease, heart disease, or cardiovascular disease) or a history of such diseases. 4.Individuals currently undergoing treatment for a disease, or those with a history of serious illness requiring medication. 5.Individuals taking pharmacy-only medicines, OTC drugs, or quasi-drugs for the purpose of nutritional supplementation (such as vitamins) or anti-fatigue. 6.Individuals who may experience allergic symptoms to the test products or severe allergic symptoms to the provided standardized meals. 7.Individuals who participated in other clinical studies within one month prior to providing consent for this study, or those scheduled to participate in other clinical studies after providing consent. 8.Individuals who may change their lifestyle habits, including diet and exercise, during the study period. 9.Others judged unsuitable for the study by the principal investigator. Target Size - 22

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 02 Month 27 Day Date of IRB - 2025 Year 02 Month 27 Day Anticipated trial start date - 2025 Year 03 Month 10 Day Last follow-up date - 2025 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069287

Disclaimer: Curated by HT Syndication.