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NCT Number: NCT06749704

Effect of High Protein Diet on Hepatic Steatosis in Patients With MAFLD

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.

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Key information

Conditions

Metabolic Dysfunction Associated Fatty Liver Disease Metabolic Diseases Mitochondrial Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high protein diet

Dietary Supplement

High protein diet

normal protein diet

Dietary Supplement

Normal protein diet

Primary outcomes

  1. Assessment of Hepatic steatosis.

    Time frame: 3 months

    Changes in hepatic steatosis at baseline and follow up would be done using fibro scan (CAP) and Computed Tomography (Liver Attenuation Index).

Secondary outcomes

  1. Assessment of cellular bioenergetics would be done.

    Time frame: 3 months

    Changes in oxygen consumption rate (OCR in pmol/min) at baseline and follow up would be done using Seahorse XF analyser.

  2. Assessment of cellular bioenergetics would be done.

    Time frame: 3 months

    Changes in Extracellular acidification rate(ECAR in mph/min) at baseline and follow up would be done using Seahorse XF analyser.

  3. Assessment of systemic bioenergetics would be done.

    Time frame: 3 months

    A switch in Respiratory quotient (RQ) at fasting and OGTT would be assessed using indirect calorimetry at baseline and follow up.

  4. Assessment of metabolic markers at baseline and follow up.

    Time frame: 3 months

    Changes in metabolic markers would be done at baseline and follow up. The following metabolic markers would be assessed :- Blood pressure(systolic and dystolic), HbA1c,Thyroid stimulating hormone , Total lipid profile, CRP levels.

  5. Assessment of muscle mass.

    Time frame: 3 months

    Assessment of muscle mass would be done by DEXA scan at baseline and follow up.

  6. Assessment of serum levels of FGF21(in ng/ml) and leptin(in ng/ml).

    Time frame: 3 months

    Assessments would be done using commercially available Elisa kits at baseline and follow up.

  7. Assessment of serum levels of adiponectin(in μg/mL).

    Time frame: 3 months

    Assessments would be done using commercially available Elisa kits at baseline and follow up.

  8. Assessment of serum levels of insulin(in μU/mL)

    Time frame: 3 months

    Assessments would be done using commercially available Elisa kits at baseline and follow up.

  9. Assessment of serum levels of glucagon(in pg/mL).

    Time frame: 3 months

    Assessments would be done using commercially available Elisa kits at baseline and follow up.

  10. Assessment of serum levels of glucagon like peptide(GLP-1) (in pmol/L)

    Time frame: 3 months

    Assessments would be done using commercially available Elisa kits at baseline and follow up.

  11. Assessment of serum levels of ghrelin (in fmol/ml).

    Time frame: 3 months

    Assessments would be done using commercially available Elisa kits at baseline and follow up.

  12. Assessment of serum levels of cholecystokinin (in pmol/liter).

    Time frame: 3 months

    Assessments would be done using commercially available Elisa kits at baseline and follow up.

Study contacts

Contact information is provided by the study sponsor or research team.

Kanika Jain, MSc

CONTACT

[email protected]

08076030183

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

Effect of High Protein Diet on Hepatic Steatosis, Inflammation and Mitochondrial Bioenergetics in Patients With MAFLD : A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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