Metabolic Dysfunction Associated Fatty Liver DiseaseNCT06749704
Effect of High Protein Diet on Hepatic Steatosis in Patients With MAFLD
A study testing High protein diet and Normal Protein diet in people with Metabolic Dysfunction Associated Fatty Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metabolic Dysfunction Associated Fatty Liver Disease
- What is being tested?
- High protein diet and Normal Protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIndia
- Study dates
- 27 Dec 2024to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Newly diagnosed treatment naïve consenting adults with MAFLD (controlled attenuation parameter; CAP >250, BMI>23 and/or DM) Age 18-65 years
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Institute of Liver and Biliary Sciences
Delhi, New Delhi, 110070
Jaya Benjamin, Dr, 9540951081, jayabenjaminilbs@gmail.com
Kanika Jain, MSc, 8076030183, kanikjain@gmail.com
About this study
Official title: Effect of High Protein Diet on Hepatic Steatosis, Inflammation and Mitochondrial Bioenergetics in Patients With MAFLD : A Randomized Controlled 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.
Read the 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.
- Being tested
- High protein diet, Normal Protein diet
- Keywords
- mitochondrial dysfunction, metabolic inflexibility, FGF21 resistance
- Medical subject headings
- Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein dietDietary supplement
High protein diet
Normal Protein dietDietary supplement
Normal protein diet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: High protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (12)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Assessment of muscle mass.
Assessment of muscle mass would be done by DEXA scan at baseline and follow up.
Measured: 3 months
Assessment of serum levels of FGF21(in ng/ml) and leptin(in ng/ml).
Assessments would be done using commercially available Elisa kits at baseline and follow up.
Measured: 3 months
Assessment of serum levels of adiponectin(in μg/mL).
Assessments would be done using commercially available Elisa kits at baseline and follow up.
Measured: 3 months
Assessment of serum levels of insulin(in μU/mL)
Assessments would be done using commercially available Elisa kits at baseline and follow up.
Measured: 3 months
Assessment of serum levels of glucagon(in pg/mL).
Assessments would be done using commercially available Elisa kits at baseline and follow up.
Measured: 3 months
Assessment of serum levels of glucagon like peptide(GLP-1) (in pmol/L)
Assessments would be done using commercially available Elisa kits at baseline and follow up.
Measured: 3 months
Assessment of serum levels of ghrelin (in fmol/ml).
Assessments would be done using commercially available Elisa kits at baseline and follow up.
Measured: 3 months
Assessment of serum levels of cholecystokinin (in pmol/liter).
Assessments would be done using commercially available Elisa kits at baseline and follow up.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start27 Dec 2024 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction Associated Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open Label
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaya Benjamin, PhD, Study director, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749704
- Sponsor's protocol ID
- ILBS-MAFLD-01
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Protein Diet on Hepatic Steatosis, Inflammation and Mitochondrial Bioenergetics in Patients With MAFLD : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06749704
- Acronym / sponsor ID
- ILBS-MAFLD-01
- Keywords
- mitochondrial dysfunction, metabolic inflexibility, FGF21 resistance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 27 Dec 2024 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open Label
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment Group | Active comparator | Dietary Supplement: Normal Protein dietThe 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. |
| High Protein Diet | Experimental | Dietary Supplement: High protein dietThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Newly diagnosed treatment naïve consenting adults with MAFLD (controlled attenuation parameter; CAP >250, BMI>23 and/or DM) Age 18-65 years
Key exclusion criteria (7 listed)
- • Lean (BMI <23) patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High protein dietHigh protein diet | Dietary supplement | High Protein Diet |
| Normal Protein dietNormal protein diet | Dietary supplement | Standard Treatment Group |
Primary outcome
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).
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaya Benjamin, PhD study director
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High protein diet and Normal Protein diet in people with Metabolic Dysfunction Associated Fatty Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kanika Jain, MSc (08076030183, kanikjain@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Hepatic steatosis. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.