CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Saturated Fat- Desi Ghee (Clarified Butter) +1 moredietary
Likely dose
Not stated in record
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Search/NCT04084522
NCT04084522N/ACompleted

Effect of Saturated Fat (Desi Ghee) on Gut-Liver Axis in Alcoholic Hepatitis

Institute of Liver and Biliary Sciences, India·interventional·Posted Sep 10, 2019·Updated Mar 31, 2022

In Brief

A clinical study evaluating Saturated Fat- Desi Ghee (Clarified Butter) and Soyabean Oil for Alcoholic Hepatitis. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The pathogenesis of the alcoholic liver disease (ALD) is a complex interplay of various etiopathological factors other than direct alcohol toxicity. These factors include inflammation \& oxidative stress, dysbiosis, intestinal hyperpermeability, and endotoxemia. Dietary fats not only improve nutritional status in ALD but specific properties of saturated fats (SF) have the potential to favourably modulate these causative factors. This project has two parts, in the animal study 10 groups of murine model of alcoholic hepatitis (AH) would be given SF in the form of Desi Ghee and in the human study patients with AH would be randomized into two groups, one with SF ( Desi Ghee) and the other with usual unsaturated fat (cooking oil). In all effect of SF on gut microbiota, hepatic steatosis, TLR-4 expression, serum adiponectin, endotoxin levels, intestinal tight junction proteins and inflammatory markers in murine models of AH, along with hepatic morbidity \& lipid profile, in patients with ALD would be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 10, 2019
Enrollment StartOct 1, 2019
Primary CompletionJan 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.8 years ago

Interventions

Saturated Fat- Desi Ghee (Clarified Butter)dietary

Desi Ghee which is also known as clarified butter contains around 70% of saturated fat. in India it is one of the important culinary items which promotes longevity and protects against various diseases, attributing numerous health benefits. Ghee consumption has also significant hypolipidemic and hypocholesterolemic effects.

Soyabean Oildietary

Soyabean Oil consists of around 84% of unsaturated fat and is the most widely used source of unsaturated fat used in the area.