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Behavioural Intervention

Mediterranean Diet vs Western Diet for Autoimmune Hepatitis

N/A

Recruiting

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Established autoimmune hepatitis (AIH) confirmed according to simplified criteria (>6) or historical confirmatory liver biopsy with inflammation consistent with AIH

Current age: 18 to 80 years old

Must not have

History of liver transplantation

Concurrent diagnosis of celiac disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of two different diets, Western Diet and Mediterranean Diet, on quality-of-life parameters in patients with AIH. Participants will try both diets in two separate phases, and will

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include digestive adjustments or food sensitivities as the body adapts to new eating patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with autoimmune hepatitis.

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a liver transplant.

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I have been diagnosed with celiac disease.

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I have been diagnosed with a variant syndrome combining AIH and another liver condition.

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My liver function is severely impaired.

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I have advanced liver disease with symptoms like fluid in the abdomen, jaundice, or bleeding from enlarged veins in my esophagus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in clinical fatigue via Promis 29

Secondary study objectives

Change in IgG value

Change in alanine transaminase (ALT) value

Change in overall health related quality of life via Promis 29

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Mediterranean Diet (MD)Active Control1 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 Control1 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.

0 / 7Eligibility criteria met