NCT05968378

Diet, Immunometabolism and Non-alcoholic Fatty Liver Disease

Immunometabolic Effects of Time Restricted Eating in Non-alcoholic Fatty Liver Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University College Dublin · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the impact of 8-hour time restricted eating (8 hours of eating, 16 hours fasting) combined with a Mediterranean diet on metabolism and inflammation in adults with non-alcoholic fatty liver disease (NAFLD).

Detailed description

Non-alcoholic fatty liver disease (NAFLD), defined as the accumulation of fat in the liver that is not related to alcohol intake, is the number 1 global cause of chronic liver disease. Excessive consumption of energy, saturated fat, and simple sugars is a key contributor to hepatic lipid accumulation and obesity-induced metabolic inflammation, reflecting cross-talk between immune and metabolic pathways. Moreover, dietary factors including saturated fatty acids, cholesterol, and their derivatives, as well as gut-derived metabolites, can prime innate immune cells to induce an exaggerated pro-inflammatory response upon re-exposure to such stimuli and may contribute to chronic low grade inflammation. Dietary strategies focusing on replacing inflammatory dietary triggers with monounsaturated fats, fiber and complex carbohydrates have been shown to improve metabolic dysfunction, but how this relates to a rewiring of the innate immune system is less clear. Time-restricted eating (TRE) is another dietary strategy which has been shown to elicit beneficial effects that reduce the risk of chronic metabolic disease and consolidates eating to a 6-10 hour period daily. Early TRE (eTRE), wherein eating occurs from morning to early afternoon, is associated with greater cardiometabolic health benefits than eating late in the evening. This includes improved insulin sensitivity, glucose tolerance and lipid metabolism, and reduced inflammatory markers. This study will determine the impact of an 8-week intervention of 8-hour eTRE combined with an anti-inflammatory Mediterranean diet on the metabolic and immune phenotype of individuals with NAFLD, a population at high risk of progressive cardiometabolic decline and chronic inflammation. By focusing on improving both nutrient quality and nutrient timing, a greater understanding of the interaction between systemic metabolism and immune cell rewiring will be gained.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Liver Fat
• Obesity
• Inflammation

Interventions

Type	Name	Description
BEHAVIORAL	Standard healthy eating advice	Subjects in this group will be provided with standard healthy eating advice according to the Irish National Healthy Eating Guidelines and Food Pyramid and will be asked to follow this advice for 8-weeks.
BEHAVIORAL	eTRE plus Mediterranean diet	Subjects in this group will be asked to consume all meals between 8am - 4pm and to adhere to a Mediterranean style diet daily for 8-weeks.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-06-01
• Completion: 2024-07-01
• First posted: 2023-08-01
• Last updated: 2023-08-01

Locations

1 site across 1 country: Ireland