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

NCT06749704 | Not Yet Recruiting

• 1 other identifier: ILBS-MAFLD-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Dysfunction Associated Fatty Liver Disease

Keywords

mitochondrial dysfunction; metabolic inflexibility; FGF21 resistance

Outcome Measures

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).

  3 months

Secondary Outcomes (12)

• Assessment of cellular bioenergetics would be done.

  3 months

• 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

Study Arms (2)

Standard Treatment Group

ACTIVE COMPARATOR

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.

Dietary Supplement: Normal Protein diet

High Protein Diet

EXPERIMENTAL

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.

Dietary Supplement: High protein diet

Interventions

High protein diet DIETARY_SUPPLEMENT

High protein diet

High Protein Diet

Normal Protein diet DIETARY_SUPPLEMENT

Normal protein diet

Standard Treatment Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

Delhi, New Delhi, 110070, India

Location

MeSH Terms

Conditions

Mitochondrial Diseases

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jaya Benjamin, PhD

  Institute of Liver and Biliary Sciences

  STUDY DIRECTOR

Central Study Contacts

Kanika Jain, MSc

CONTACT

08076030183; kanikjain@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As it is a nutritional intervention study masking either the participant or the investigator is not possible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Label

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: December 27, 2024
• Study Start: December 27, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-05

Locations

IN (1)