Randomized Crossover Study Comparing Mediterranean and Western Diets for Reducing Fatigue in Patients with Autoimmune Hepatitis

What this Trial Is About

Researchers are evaluating the effects of two different diets, the Western Diet WD and the Mediterranean Diet MD, on quality of life and fatigue in patients with autoimmune hepatitis AIH. This pilot study uses a randomized crossover design to compare these dietary treatments and their impact on symptoms, especially fatigue, which is a major concern for AIH patients. The study aims to explore whether diet can help reduce symptom burden in AIH, a condition known to significantly lower patients quality of life. Participants will be randomly assigned to one of two diet groups the Mediterranean Diet or the Western Diet. Each participant will follow one diet for 8 weeks, then after a 6-week washout period, switch to the other diet for another 8 weeks. The Mediterranean Diet emphasizes vegetables, fruits, whole grains, dairy, protein foods including seafood, and healthy oils, with limited added sugars and saturated fats. The Western Diet includes lower amounts of fruits and vegetables and higher levels of saturated fat and added sugars, matching typical consumption patterns by age and gender. Both diets will be carefully prepared to maintain participants weight stability. During the 24-week study, participants will be monitored for changes in fatigue using the PROMIS-29 Fatigue Domain score, as well as overall quality of life, liver stiffness and fat content, and liver-related blood tests including ALT and IgG levels. Assessments will occur at scheduled intervals, and participants will receive weekly frozen food deliveries. The study team and participants will remain unaware of which diet is being provided at each phase to maintain study integrity.

Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients