NCT06749704Not yet recruiting
Effect of High Protein Diet on Hepatic Steatosis in Patients With MAFLD
Effect of High Protein Diet on Hepatic Steatosis, Inflammation and Mitochondrial Bioenergetics in Patients With MAFLD : A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 27 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 6 May 2024
- Start date
- 27 Dec 2024
- Primary completion date
- 1 May 2027
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06749704
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 27 Dec 2024 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • 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
Who the study is looking for
- Newly diagnosed treatment naïve consenting adults with MAFLD (controlled attenuation parameter; CAP \>250, BMI\>23 and/or DM) Age 18-65 years
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Liver and Biliary Sciences Coordinator of this site? Confirm its status | Delhi | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.