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Behavioural Intervention

Mediterranean Diet (MD) 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in clinical fatigue via Promis 29

Secondary outcome measures

Change in IgG value

Change in alanine transaminase (ALT) value

Change in overall health related quality of life via Promis 29

+1 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

981,714 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would it be possible for me to participate in this medical study?

"Candidates eligible for this study must have autoimmune hepatitis and fall within the age range of 18 to 80 years. The trial aims to recruit a total of 48 participants."

Answered by AI

Are there still opportunities for potential participants to enroll in this clinical trial?

"According to information available on clinicaltrials.gov, this trial is currently in the recruitment phase. The study was initially listed on 10/23/2023 and most recently updated on 2/1/2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients

Craig Lammert 2023. "Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06250309.

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