Effect of High Protein Diet on Hepatic Steatosis in Patients With MAFLD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High protein diet, Normal Protein diet.
- Who it may be relevant to
- Registry conditions: Metabolic Dysfunction Associated Fatty Liver Disease. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of High Protein Diet on Hepatic Steatosis, Inflammation and Mitochondrial Bioenergetics in Patients With MAFLD : A Randomized Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Dietary supplement High protein diet
High protein diet - Dietary supplement Normal Protein diet
Normal protein diet
Primary outcome measures
- Assessment of Hepatic steatosis. [Time frame: 3 months]
Secondary outcome measures (12)
- Assessment of cellular bioenergetics would be done. [Time frame: 3 months]
- Assessment of cellular bioenergetics would be done. [Time frame: 3 months]
- Assessment of systemic bioenergetics would be done. [Time frame: 3 months]
- Assessment of metabolic markers at baseline and follow up. [Time frame: 3 months]
- Assessment of muscle mass. [Time frame: 3 months]
- Assessment of serum levels of FGF21(in ng/ml) and leptin(in ng/ml). [Time frame: 3 months]
- Assessment of serum levels of adiponectin(in μg/mL). [Time frame: 3 months]
- Assessment of serum levels of insulin(in μU/mL) [Time frame: 3 months]
- Assessment of serum levels of glucagon(in pg/mL). [Time frame: 3 months]
- Assessment of serum levels of glucagon like peptide(GLP-1) (in pmol/L) [Time frame: 3 months]
- Assessment of serum levels of ghrelin (in fmol/ml). [Time frame: 3 months]
- Assessment of serum levels of cholecystokinin (in pmol/liter). [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Newly diagnosed treatment naïve consenting adults with MAFLD (controlled attenuation parameter; CAP >250, BMI>23 and/or DM) Age 18-65 years
Exclusion criteria
- • 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
India · 1 center
- Institute of Liver and Biliary Sciences — Delhi
Identifiers
NCT: NCT06749704 · ILBS-MAFLD-01