Tokyo, March 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060811) titled 'A 3-Month Prospective Study of Combined Exercise and Nutritional Counseling in Hospital Staff: Effects on Liver Function, Body Composition, and Lifestyle' on March 5.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Okayama University
Condition:
Condition - A 3-Month Prospective Study of Combined Exercise and Nutritional Counseling in Hospital Staff: Effects on Liver Function, Body Composition, and Lifestyle
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Fatty liver disease, lifestyle-related diseases, and chronic kidney disease are rapidly increasing. Hepatic steatosis can lead to liver fibrosis and is frequently accompanied by obesity, impaired glucose metabolism, hypertension, and other comorbidities. Increasing physical activity through aerobic exercise and resistance training, together with optimizing caloric and salt intake, is presumed to improve liver function and metabolic parameters.1) In this study, we combined exercise counseling, a dietary intervention provided by registered dietitians, and body composition assessment using InBody, and evaluated the usefulness of a 3-month intervention by examining its effects on liver function, metabolic parameters, body composition, and lifestyle behaviors.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Exercise guidance using a YouTube playlist
Dietary intervention by a registered dietitian
Body composition assessment using InBody
These components are combined to evaluate the effects of a 3-month intervention on liver function, metabolic parameters, body composition, and lifestyle behaviors.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - Eligible participants are in-hospital staff members of Shigei Hospital who wish to attend the staff-oriented fatty liver clinic and who meet at least one of the following criteria. Participants must receive a full explanation of the study and provide written informed consent based on sufficient understanding and voluntary agreement.
Body mass index (BMI) >= 23 kg/m2 and waist circumference >= 94 cm in men or >= 80 cm in women.
Fasting plasma glucose >= 100 mg/dL, HbA1c >= 5.7%, diagnosis of type 2 diabetes mellitus, or current use of antidiabetic medication.
Blood pressure >= 135/85 mmHg or current use of antihypertensive medication.
Triglycerides >= 150 mg/dL or current use of lipid-lowering medication.
Low HDL cholesterol: = 65 years.
Presence of liver cirrhosis, cardiovascular disease, malignant neoplasm, pregnancy, or severe limitations in physical activity.
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 03 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069302
Disclaimer: Curated by HT Syndication.
