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临床试验/CTRI/2025/05/086849
CTRI/2025/05/086849尚未招募不适用

Effectiveness of calorie restricted diet combined with structured resistance training versus ad libitium physical activity on hepatic steatosis in patients with non-alcoholic fatty liver: A RCT.

Institute of Liver and Biliary Sciences1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年1月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
140
试验地点
1
主要终点
effectiveness of calorie-restricted diet combined with structured resistance training versus ad libitium physical activity on hepatic steatosis as assessed by Controlled Attenuation Parameter values in patients with non-alcoholic fatty liver

研究概览

简要总结

Non-Alcoholic Fatty Liver Disease is a chroniccondition marked by excessive fat accumulation in the liver, not linked toalcohol consumption. Globally, it affects 25–29% of the population, withprevalence in Asia, including India, ranging from 9% to 53%, influencedby demographics and socioeconomic factors**.**NAFLD can progressto severe liver conditions like NASH, fibrosis, cirrhosis, or liver cancer. Italso increases the risk of cardiovascular diseases, metabolic syndrome,diabetes, and kidney disorders. The healthcare costs associated with NAFLD have risensignificantly and each one-unit increase in FIB-4 scores correlates with a 3.4%rise in overall healthcare expenses. So, early intervention in terms od dietand lifestyle modification is crucial to curb these escalating costs.

Lifestylemodifications, including dietary changes and physical activity, are pivotal inNAFLD management. Calorie-restricted diets, such as low-carbohydrate,Mediterranean, and ketogenic approaches, have shown promise in reducing hepaticfat and improving metabolic health.

Different type of exerciselike aerobic and resistance training offers unique and complementary benefitsto individuals but, resistance training has additional benefits interms of building and maintaining lean muscle mass, reducing risk of injury,feasibility in cardiopulmonary compromised and obese patients. So, it isimportant to make use of this modality in NAFLD management.

Although resistance exercise is promising forNAFLD management but, significant research gaps exist regarding its optimalapplication, standardized protocols, duration and clinical outcomes. So, wehypothesized that a calorie-restricted diet combined with structured resistancetraining (150 minutes/week) will be feasible and effective.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patient aged between 18-65 years
  • Newly diagnosed cases of non-alcoholic fatty liver via transient elastography
  • Ability to give informed consent to participate in the study.

排除标准

  • Any known secondary liver disease, including hepatitis B surface antigen or anti-hepatitis C virus antibodies.
  • Excessive alcohol consumption
  • Administration of medical treatment that may elevate alanine aminotransferase (ALT) or lead to hepatic steatosis (Drugs like amiodarone, risperidone, olanzapine, and valproic acid, etc).
  • Known diabetes and on multiple oral hypoglycaemic agents, or insulin.
  • Pregnant females, irrespective of gestational age.
  • Major chronic diseases including: renal, cardiovascular, lung, uncontrolled hypertension, inflammatory bowel disease, any malignancy and autoimmune disorders.
  • Orthopaedic contraindications for structured resistance training.

结局指标

主要结局

effectiveness of calorie-restricted diet combined with structured resistance training versus ad libitium physical activity on hepatic steatosis as assessed by Controlled Attenuation Parameter values in patients with non-alcoholic fatty liver

时间窗: BASELINE, 1MONTH, 3MONTH AND 6 MONTHS

次要结局

  • changes in Anthropometric, Body composition, Cardiometabolic, Biochemical parameters and hand grip strength among both the groups(BASELINE, 1MONTH, 3MONTH AND 6 MONTHS)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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