Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients

Conditions

• Autoimmune Hepatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Dietary assignment — DIETARY_SUPPLEMENT
  A total of 48 subjects will be randomized by a computer program into one of two groups: MD or WD. Participation in each dietary arm lasts 8 weeks, with a 6 week washout period in between each arm.

Study Details

This is a single-center, proof-of-concept pilot study which uses a cross-over design to compare two dietary interventions/treatments: Western Diet (WD) vs Mediterranean (MD) and impact on quality-of-life parameters in AIH. Participants will receive both treatments through two phases and will be divided into two groups.

Key Dates

Start date

Oct 23, 2023

Status verified

May 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

48 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: Mediterranean Diet (MD)
  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).
• Active Comparator: Western Diet (WD)
  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.

Primary Outcome Measure

Change in clinical fatigue via Promis 29 [ Time Frame: 24 weeks ]

Central Contacts

• Kelsey Green, MPH
  317-278-9292
  [email protected]
• Regina Weber, BS
  317-278-3584
  [email protected]

Locations (1)

Find similar trials in Indianapolis, IN

Related Studies

• A-LiNK: Improving Outcomes in Autoimmune Liver Disease
  Recruiting · Children's Hospital Medical Center, Cincinnati · Palo Alto, California
• MRI Based Biomarkers in Pediatric Autoimmune Liver Disease
  Recruiting · Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio
• MRI Biomarkers in as Predictor of Clinical Endpoints in Pediatric Autoimmune Liver Disease
  Recruiting · Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio
• TruGraf Liver Gene Expression Serial Test
  Enrolling By Invitation · Washington University School of Medicine · St Louis, Missouri