Randomized Crossover Diet Study Comparing Impact of Mediterranean Diet to Western Diet on Fatigue in Autoimmune Hepatitis Patients

Status: Recruiting

Location: See location...

Intervention Type: Dietary supplement

Study Type: Interventional

Study Phase: Not Applicable

SUMMARY

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 80

Healthy Volunteers: f

View:

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

• Therapeutically stable AIH: no changes to immunosuppression (corticosteroids or baseline immunosuppression) within 4 weeks of study enrollment

• Previous enrollment in the Indiana University GRACE study

• Fatigue domain score (PROMIS-29) more than population mean (PROMIS 29 score): T-score ≥ 55

• Diagnosis of AIH \> 6 months

• Current age: 18 to 80 years old

• Willing and agree to comply with protocol requirements

• Female patients who are of reproductive potential must agree for the duration of the study to use an effective means of contraception (e.g., abstinence, hormonal contraception methods that inhibit ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal ligation, vasectomized partner)

• Capable of storing 1 week duration of frozen food and preparing meals

• Capable of receiving weekly frozen food on scheduled day of delivery

• Capable of understanding and signing the informed consent document

Locations

United States

Indiana

IU Health University Hosptial

RECRUITING

Indianapolis

Contact Information

Primary

Kelsey Green, MPH

greenke@iu.edu

317-278-9292

Backup

Regina Weber, BS

reginaw@iu.edu

317-278-3584

Time Frame

Start Date: 2023-10-23

Estimated Completion Date: 2028-12-31

Participants

Target number of participants: 48

Treatments

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.

Related Therapeutic Areas

Autoimmune Hepatitis

Hepatitis

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Randomized Crossover Diet Study Comparing Impact of Mediterranean Diet to Western Diet on Fatigue in Autoimmune Hepatitis Patients

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