Effect of High Protein Diet on Hepatic Steatosis, Inflammation and Mitochondrial Bioenergetics in Patients With MAFLD : A Randomized Controlled Trial
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
- Assessment of Hepatic steatosis.
研究概览
简要总结
MAFLD is a growing problem in India. Its pathophysiology is complex, but focused on abnormal substrate handling due to mitochondrial dysfunction reflecting as metabolic inflexibility. Nutrition is the cornerstone of management. The ideal macronutrient distribution within a hypocaloric diet is not known yet. Evidence from experimental and a few human studies in obese, highlight the role of dietary proteins, independent of calorie restriction, in reducing hepatic steatosis by improving the cellular and systemic bioenergetics.
详细描述
Novelty: First study to assess the effect of high protein diet (HPD) in comparison to a standard protein diet (SPD) within a calorie restricted diet, on both the cellular and systemic bioenergetics in patients with MAFLD.
Objectives: Aims to see the effect of HPD on hepatic steatosis, cellular and systemic bioenergetics, along with metabolic parameters in patients with MAFLD.
Method: In this RCT, patients with MAFLD (n=140) with or without MS, would be randomized into HPD or SPD groups (i.e. 70 in each group), and parameters like hepatic steatosis (CAP by Transient elastography (FibroScan), cellular bioenergetics by oxygen consumption rate (OCR) and extracellular acidification rate (ECAR) as measured using Seahorse Analyzer, and Indirect Calorimetry will be used to assess the fasting and postglucose challenge (Oral glucose tolerance test) REE and RQ. DEXA scan would be used to assess body composition apart from routine blood tests to assess features of Metabolic syndrome. The serum levels of GLP1, CKK, Ghrelin, FGF21, Adipokines like leptin and adiponectin, NADH/NAD ratio, insulin and glucagon would be measured.
Outcome: A HPD is expected to improve hepatic steatosis, blunted fuel switching (RQ) and cellular bioenergetics (OCR) along with metabolic parameters in patients with MAFLD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
As it is a nutritional intervention study masking either the participant or the investigator is not possible
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed treatment naïve consenting adults with MAFLD (controlled attenuation parameter; CAP >250, BMI>23 and/or DM) Age 18-65 years
排除标准
- •• Lean (BMI <23) patients
- •Age <18 and >65 years
- •Individuals who had been hospitalized with complications of Diabetes mellitus, Chronic Kidney disease, Hypertension in the previous 6 months
- •Patients with viral hepatitis
- •Patients with significant alcohol consumption (regular consumption of > 10g per day for females and > 20g/d in males),
- •Patients having chronic inflammatory bowel disease or any chronic and autoimmune diseases will be excluded
- •Pregnant & lactating women
研究组 & 干预措施
Standard Treatment Group
The intervention is planned as a supervised dietary supplementation, with a goal of restricting the calorie intake to 20 Kcal/Kg BW/day, with a protein intake of 0.9 gm/Kg BW/day i.e., around 15 % of total calories from protein, 25% from fats and 60% from carbohydrates.
Physical activity recommendations: Brisk walking on a treadmill (at a speed 5-6 Kmph for 60 minutes) OR 5000 steps per day by pedometer counting.
干预措施: Normal Protein diet (Dietary Supplement)
High Protein Diet
The intervention is planned as a supervised dietary supplementation, with a goal of restricting the calorie intake to 20 Kcal/Kg BW/day, with a protein intake of 1.3 gm/Kg BW/day i.e., around 25 % of total calories from protein, 25% from fats and 50% from carbohydrates. Major portion of the protein would be met by dairy, legumes and pulses along with egg whites.
Physical activity recommendations: Brisk walking on a treadmill (at a speed 5-6 Kmph for 60 minutes) OR 5000 steps per day by pedometer counting.
干预措施: High protein diet (Dietary Supplement)
结局指标
主要结局
Assessment of Hepatic steatosis.
时间窗: 3 months
Changes in hepatic steatosis at baseline and follow up would be done using fibro scan (CAP) and Computed Tomography (Liver Attenuation Index).
次要结局
- Assessment of cellular bioenergetics would be done.(3 months)
- Assessment of systemic bioenergetics would be done.(3 months)
- Assessment of metabolic markers at baseline and follow up.(3 months)
- Assessment of muscle mass.(3 months)
- Assessment of serum levels of FGF21(in ng/ml) and leptin(in ng/ml).(3 months)
- Assessment of serum levels of adiponectin(in μg/mL).(3 months)
- Assessment of serum levels of insulin(in μU/mL)(3 months)
- Assessment of serum levels of glucagon(in pg/mL).(3 months)
- Assessment of serum levels of glucagon like peptide(GLP-1) (in pmol/L)(3 months)
- Assessment of serum levels of ghrelin (in fmol/ml).(3 months)
- Assessment of serum levels of cholecystokinin (in pmol/liter).(3 months)