To compare the effect of Indo-Mediterranean Diet with continuous energy restriction diet on hepatic steatosis and fibrosis, body composition, and metabolic parameters in adults with non-alcoholic fatty liver disease
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Improvement in Controlled Attenuation Parameter (CAP), Liver Stiffness Measurement (LSM), body weight, body composition, and metabolic parameters in NAFLD patients
研究概览
简要总结
Non-alcoholic fatty liverdisease (NAFLD) is emerging as the most common chronic liver disease. [1] Currently, there is no consensus concerning thepharmacological treatment of NAFLD. However, lifestyle interventions based onexercise and a balanced diet for quality and quantity, are considered thecornerstone of NAFLD management.
Research question**:** The research question here is, doesthe IMD is better than CER in improving liver steatosis,fibrosis, body composition and metabolic parameters. It is also important to comparethe impact of these diets on other NAFLD related biomarkers. At last, apart from above mentioned parameters the studywill also compare the effect of IMD and CER on, sleep quality, quality of lifeand adherence to the diet.
Methodology: 150 NAFLD patients will be included in the study and divided into2 groups 75 in each group. Patients will be assessed at baseline for the liversteatosis and fibrosis, clinical, anthropometric, biochemical and metabolicparameters. They will be provided with the intervention and the outcomes willbe assessed at 1.5 months and final outcomes at 3 months.
Proposed outcome: It is expected that after 3 months of intervention improvement inliver steatosis and fibrosis, clinical, anthropometric, biochemical and metabolicparameters will be observed in the intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18-60 years will be included.
- •Patients enrolled in the study need to be diagnosed with non-alcoholic fatty liver disease.
- •Patients should have a Body Mass Index (BMI) of ≥ 25 kg/m
- •Adult patients will be willing to participate and ensure cooperation in the study.
排除标准
- •Patients undergoing the treatment or recently diagnosed diabetes mellitus.
- •Participants who have undergone any recent (in the last three months) major surgery.
- •Patients with any acute or chronic infectious illness are excluded.
- •Patients with a history of pancreatitis or other diseases who require any dietary modifications/restrictions.
- •Patients with chronic heart and kidney disease and advanced end-organ damage are excluded from the study.
- •Patients who have chronic hepatitis are excluded.
- •Any Pregnant and lactating women are excluded from the study.
- •Patients who consume excessive alcohol (>20 g/day for women and >30 g/day for men).
- •Currently (in the last three months) enrolled or have been a part of any other intervention program study are excluded.
结局指标
主要结局
Improvement in Controlled Attenuation Parameter (CAP), Liver Stiffness Measurement (LSM), body weight, body composition, and metabolic parameters in NAFLD patients
时间窗: Changes in CAP, Liver Stiffness Measurement (LSM), and metabolic parameters in NAFLD patients
次要结局
- The secondary outcome is to assess the improvement in biomarkers, energy expenditure, sleep quality, any subclinical inflammation, & quality of life. It also include the assessment of adherence to the dietary regime provided in the study.(BASELINE, 6 WEEKS (1.5 months), 12 WEEKS (3 months))