Tokyo, April 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061121) titled 'Nutritional Intervention Trial to Improve Liver Function Related Blood Biomarkers in Heavyweight Athletes' on April 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Nihon University

Condition: Condition - obesity Liver dysfunction Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to identify factors that influence blood biomarkers related to liver function in athletes and to examine nutritional strategies aimed at improving these biomarkers. To achieve this, a three-month nutrition counseling program conducted by a registered dietitian will be implemented. By targeting athletes with impaired liver function, this study aims to clarify dietary approaches that may improve liver dysfunction that is non-alcoholic in origin and not attributable to physical inactivity or overeating. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will be selected based on screening blood tests, specifically those with AST and ALT levels of >30 mg/dL and not markedly exceeding 40 mg/dL. Individuals who are found to have fatty liver on MRI and are deemed to require medical treatment will be excluded. The athletes who meet the criteria will undergo approximately three months of nutrition management provided by a registered dietitian, with the aim of improving liver function. Body composition, blood, salivary, ultrasound, and MRI biomarkers, as well as nutrient intake, will be assessed before and after the intervention to evaluate the effects of the nutritional program.

Eligibility: Age-lower limit - 18 years-old = Gender - Male Key inclusion criteria - Individuals will be selected based on screening blood tests conducted in heavyweight athletes, specifically those with AST and ALT levels of >30 mg/dL and not markedly exceeding 40 mg/dL. Key exclusion criteria - Participants who are found to have fatty liver on MRI and are judged by a physician to require medical treatment will be excluded from the study. Target Size - 15

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 05 Month 15 Day Date of IRB - 2025 Year 05 Month 15 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069936

Disclaimer: Curated by HT Syndication.