Effect of High Protein Diet on Hepatic Steatosis in Patients With MAFLD
NCT ID: NCT06749704
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
140 participants
INTERVENTIONAL
2024-12-27
2027-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Normal Protein diet
Normal protein diet
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.
High protein diet
High protein diet
Interventions
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High protein diet
High protein diet
Normal Protein diet
Normal protein diet
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Principal Investigators
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Jaya Benjamin, PhD
Role: STUDY_DIRECTOR
Institute of Liver and Biliary Sciences
Locations
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Institute of Liver and Biliary Sciences
Delhi, New Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Jaya Benjamin, Dr
Role: primary
Kanika Jain, MSc
Role: backup
Other Identifiers
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ILBS-MAFLD-01
Identifier Type: -
Identifier Source: org_study_id