Mediterranean Diet vs Western Diet for Autoimmune Hepatitis

Overseen By Regina Weber, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Celiac disease, Variant syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different diets affect the quality of life in people with autoimmune hepatitis (AIH). Participants will try both a Mediterranean Diet, rich in fruits, vegetables, and healthy fats, and a Western Diet, higher in saturated fats and sugars. The aim is to determine which diet might improve symptoms or overall well-being. Individuals with a stable AIH diagnosis for over six months and no recent changes in medication may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to understanding dietary impacts on AIH.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, your autoimmune hepatitis treatment must be stable, with no changes to your immunosuppression medications within 4 weeks before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has examined both the Mediterranean and Western diets for their effects on people with autoimmune hepatitis. Studies suggest that the Mediterranean Diet is generally easy to follow and may improve quality of life by reducing tiredness in these patients, with no major reports of negative effects.

In contrast, the Western Diet includes more saturated fats and sugars. Although the study did not find direct evidence of harm from this diet, some research indicates it might increase inflammation, potentially making it less suitable for those with autoimmune conditions.

Overall, various studies have used both diets and generally consider them safe. Participants in the trials will try both diets to help compare their effects on quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the comparison between the Mediterranean Diet and the Western Diet for autoimmune hepatitis because these dietary approaches offer a novel way to manage the condition. Most treatments for autoimmune hepatitis currently involve immunosuppressive medications like prednisone and azathioprine. Unlike these drugs, the Mediterranean Diet emphasizes whole foods rich in fruits, vegetables, whole grains, and healthy fats, which may reduce inflammation naturally. On the other hand, the Western Diet, which is often higher in saturated fats and sugars, serves as a contrast to highlight the potential benefits of dietary change. This trial could reveal if diet alone can improve liver health and reduce reliance on medication.

What evidence suggests that this trial's dietary interventions could be effective for autoimmune hepatitis?

This trial will compare the Mediterranean Diet with the Western Diet for individuals with autoimmune hepatitis. Studies have shown that the Mediterranean Diet may improve the quality of life for people with this condition. It might reduce tiredness, a common issue for those with autoimmune hepatitis. Research suggests that this diet can also enhance liver health. The Mediterranean Diet includes plenty of fruits, vegetables, whole grains, and healthy fats like olive oil. This combination of foods is believed to support the body's natural healing processes. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with autoimmune hepatitis who experience fatigue. Participants will be part of a study comparing the effects of two diets on their quality of life.

Inclusion Criteria

I have been diagnosed with autoimmune hepatitis.

My autoimmune hepatitis treatment hasn't changed in the last 4 weeks.

Previous enrollment in the Indiana University GRACE study

Exclusion Criteria

I have had a liver transplant.

Women who are pregnant or breastfeeding or intend to become so for the entire duration of the study; this information will be self-reported; no pregnancy test will be performed

Current treatment with an investigational drug

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive the first dietary intervention (either Mediterranean Diet or Western Diet) for 12 weeks

12 weeks

Treatment Phase 2

Participants cross over to the opposite dietary intervention for another 12 weeks

12 weeks

Follow-up

Participants are monitored for changes in liver stiffness, fat content, and overall health-related quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mediterranean Diet
• Western Diet

Trial Overview The study tests how a Mediterranean Diet (MD) versus a Western Diet (WD) affects patients' fatigue levels. It's a cross-over pilot study, meaning participants will try both diets in different phases to see which one works better.

How Is the Trial Designed?

Group I: Mediterranean Diet (MD) Active Control 1 Intervention

The Mediterranean Diet (MD) includes similar food patterns to those described in the Healthy Mediterranean-Style Dietary Pattern in the Dietary Guidelines for Americans, 2020-2025. The daily caloric needs of participants will be calculated to ensure weight stability. For a daily 2,000 kcal diet, participants will consume 2.5 cup equivalents of vegetables, 2.5 cup equivalents of fruits, 3 ounce equivalents of whole grains, 2 cup equivalents of dairy, 6 ounces equivalent of protein foods (with 32% from seafood, and 11% from nuts, seeds and soy products), and 27 grams of canola or olive oil, per day. No more than 12% of calories per day will come from discretionary foods (I.e., added sugar, saturated fat).

Group II: Western Diet (WD) Active Control 1 Intervention

The Western Diet (WD) includes similar food patterns to those described in the Data Tables of What We Eat in America, NHANES (13) . We will match intake according to gender and age group in years (I.e., 20-29; 30-39; 40-49; 50-59; 60-69; 70 and over). On average, participants will consume 1.6 cup equivalent of vegetables, 0.9 cup equivalents of fruits, 0.8 ounce equivalents of whole grains,1.4 cup equivalents of dairy, 6.3 ounces equivalent of protein foods (with 10% from seafood, and 14% from nuts, seeds and soy products). The diet will contain 12% of calories per day from saturated fat, and 12.7% of calories from added sugars.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

In a study of 3,325 Iranian adults with non-alcoholic fatty liver disease (NAFLD), adherence to the Mediterranean diet was linked to lower levels of weight, total cholesterol, and LDL cholesterol, indicating potential benefits for liver health.

Higher adherence to the Mediterranean diet was associated with a 16% reduction in the odds of having hepatic fibrosis, suggesting that this diet may help protect against liver damage in NAFLD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between the Mediterranean diet and risk of hepatic fibrosis in patients with non-alcoholic fatty liver disease: A cross-sectional analysis of the RaNCD cohort. Miryan, M., Darbandi, M., Moradi, M., et al.[2023]

The Mediterranean diet (MD) is recommended for treating non-alcoholic fatty liver disease (NAFLD) as it can improve liver health and metabolic conditions even without weight loss, making it a beneficial dietary approach for patients.

Components of the MD, such as olive oil, fish, and whole grains, have been shown to positively impact NAFLD, while Western dietary elements like soft drinks and saturated fats are linked to worsening the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mediterranean dietary pattern as the diet of choice for non-alcoholic fatty liver disease: Evidence and plausible mechanisms. Zelber-Sagi, S., Salomone, F., Mlynarsky, L.[2019]

In a study of 60 adults with non-alcoholic fatty liver disease (NAFLD), those who adhered more closely to the Mediterranean diet showed significant reductions in intrahepatic fat content, liver damage markers, and improvements in cardiorespiratory fitness after a 6-month intervention.

Higher adherence to the Mediterranean diet was associated with increased antioxidant enzyme activity and decreased levels of inflammation biomarkers, indicating that this dietary approach may effectively reduce oxidative stress and inflammation in NAFLD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased Adherence to the Mediterranean Diet after Lifestyle Intervention Improves Oxidative and Inflammatory Status in Patients with Non-Alcoholic Fatty Liver Disease. Monserrat-Mesquida, M., Quetglas-Llabrés, M., Bouzas, C., et al.[2022]

The Spanish Ketogenic Mediterranean Diet (SKMD) significantly improved various health markers in 14 obese men over 12 weeks, including body weight, liver enzymes, and cholesterol levels, indicating its efficacy in treating metabolic syndrome (MS) and nonalcoholic fatty liver disease (NAFLD).

After following the SKMD, all participants were free of metabolic syndrome according to the International Diabetes Federation criteria, demonstrating the diet's potential as a safe and effective intervention for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of the Spanish Ketogenic Mediterranean Diet on nonalcoholic fatty liver disease: a pilot study. Pérez-Guisado, J., Muñoz-Serrano, A.[2017]

In a study of 247 adults, higher adherence to the Mediterranean diet was linked to a significantly lower risk of non-alcoholic fatty liver disease (NAFLD), with a 64% reduction in odds for those with the highest adherence before adjusting for body measurements.

The protective effect of the Mediterranean diet on NAFLD risk diminished after accounting for body mass index and waist/hip circumference, suggesting that weight management may play a crucial role in this relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean dietary pattern and non-alcoholic fatty liver diseases: a case-control study. Entezari, MR., Talenezhad, N., Mirzavandi, F., et al.[2022]

Observational studies indicate that following a Mediterranean diet is linked to less liver damage in individuals with non-alcoholic fatty liver disease (NAFLD).

Intervention studies show that the Mediterranean diet can lead to a significant reduction in liver fat, with a 4.4% decrease in intrahepatic lipids and up to a 10.2% reduction in liver fat as measured by magnetic resonance imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the Mediterranean diet on histological indicators and imaging tests in non-alcoholic fatty liver disease. Saavedra, Y., Mena, V., Priken, K.[2022]

During the COVID-19 lockdown, individuals with low physical activity (PA) levels improved their fitness and reduced sedentary time, leading to a decrease in gamma glutamyl transferase (GGT) levels, which is beneficial for liver health.

In contrast, those with higher PA levels experienced a decline in HDL-cholesterol and an increase in fatty liver index (FLI), indicating that stopping regular physical activity negatively impacts metabolic syndrome and non-alcoholic fatty liver disease (NAFLD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Physical Activity Differences Due to COVID-19 Pandemic Lockdown on Non-Alcoholic Fatty Liver Parameters in Adults with Metabolic Syndrome. Mascaró, CM., Bouzas, C., Montemayor, S., et al.[2022]

A Mediterranean diet with unrestricted fat intake may lower the risk of major cardiovascular events, breast cancer, and type 2 diabetes, based on a large primary prevention trial involving adults.

Higher adherence to a Mediterranean diet is associated with reduced total cancer mortality and lower incidence of colorectal cancer, although the evidence for other health outcomes remains limited and inconsistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects on Health Outcomes of a Mediterranean Diet With No Restriction on Fat Intake: A Systematic Review and Meta-analysis. Bloomfield, HE., Koeller, E., Greer, N., et al.[2022]

A Mediterranean diet supplemented with dairy foods significantly reduced systolic and diastolic blood pressure in participants at risk of cardiovascular disease, indicating improved cardiovascular health.

The MedDairy diet also led to favorable changes in cholesterol levels, including higher HDL cholesterol and lower triglycerides, suggesting it may be an effective dietary approach for managing cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mediterranean diet supplemented with dairy foods improves markers of cardiovascular risk: results from the MedDairy randomized controlled trial. Wade, AT., Davis, CR., Dyer, KA., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40368024/

Protocol for a randomized crossover diet intervention trial Effect of Mediterranean and Western diets on fatigue in patients with autoimmune hepatitis: Protocol for a randomized crossover diet intervention trial.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425001454

Protocol for a randomized crossover diet intervention trial Mediterranean diet (MD) is a potential non-pharmacological intervention to reduce fatigue and improve the quality of life in patients with autoimmune hepatitis ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06250309?cond=Autoimmune%20hepatitis%20OR%20%22%22&aggFilters=status:not%20rec&viewType=Table&rank=8

Mediterranean Diet Versus Western Diet on Fatigue in ... Autoimmune hepatitis (AIH) patients have dramatically reduced quality of life compared to healthy controls. Many symptoms that drive this reduction remain well ...

4. mdpi.com mdpi.com/2304-8158/14/10/1736

Two-Year Mediterranean Diet Intervention Improves ... Conclusions: Greater adherence to the Mediterranean diet, along with increased physical activity, significantly enhances liver health markers in individuals ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06250309/mediterranean-diet-versus-western-diet-on-fatigue-in-autoimmune-hepatitis-patients

Mediterranean Diet Versus Western Diet on Fatigue in ... Autoimmune hepatitis (AIH) patients have dramatically reduced quality of life compared to healthy controls. Many symptoms that drive this ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9544144/

Impact of a Mediterranean diet on hepatic and metabolic ... There were no between‐group differences for hepatic and metabolic outcomes when comparing MedDiet to LFD. LFD improved IHL and insulin resistance.