Health TrialsbyHealthPanel

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

ConditionMetabolic Dysfunction Associated Fatty Liver Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed treatment naïve consenting adults with MAFLD (controlled attenuation parameter; CAP >250, BMI>23 and/or DM) Age 18-65 years

Disqualifiers

• 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • High protein diet

    Dietary supplement

    High protein diet

  • Normal Protein diet

    Dietary supplement

    Normal protein diet

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Standard Treatment GroupActive comparator 1 intervention
Group B: High Protein DietExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assessment of Hepatic steatosis.

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

Time frame
3 months

Secondary outcomes

1

Assessment of cellular bioenergetics would be done.

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

Time frame
3 months
2

Assessment of cellular bioenergetics would be done.

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

Time frame
3 months
3

Assessment of systemic bioenergetics would be done.

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

Time frame
3 months
4

Assessment of metabolic markers at baseline and follow up.

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.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Liver and Biliary Sciences, India

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: