Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation in Lupus

University of Florida

Status: Terminated

Conditions: Lupus Erythematosus, Systemic

Treatments: Other: High Fermented Food Dietary Pattern; Other: Mediterranean Dietary Pattern

Study type: Interventional

Funder types: Other

Identifiers

NCT05379725

IRB202200703

Details and patient eligibility

About

This is a 4-month randomized controlled trial to evaluate the feasibility of 'good and very good' adherence to the Mediterranean dietary pattern and to a high-fermented-food diet by individuals with Systemic lupus erythematosus (SLE).

Full description

Given the demonstrated beneficial effects of the Mediterranean dietary pattern in autoimmune disease and the potential benefit of a high-fermented-food diet on inflammatory profiles, we aim to determine the feasibility and relative benefit of a Mediterranean dietary pattern versus a high-fermented-food diet on inflammatory markers and clinical outcomes in individuals with SLE. The primary aim of the study is to evaluate the feasibility of 'good and very good' adherence to the Mediterranean dietary pattern and to a high-fermented-food diet by individuals with SLE. Secondary aims will determine the effects of the Mediterranean dietary pattern and a high-fermented-food diet on attenuating inflammation and disease activity in individuals with SLE. This is a 4-month randomized controlled trial with a 1-month baseline of usual diet and 3-month intervention. Participants will complete the online DHQ III and diet adherence questionnaires monthly. Blood will be obtained at randomization and at the end of the intervention period for analysis of inflammatory cytokines. Dietary intake during baseline and intervention will be assessed by 5, ASA 24-h dietary recalls.

Enrollment: 5 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 18 years of age
• Able to provide informed consent and undertake study questionnaire completion in English
• Meets SLE diagnostic criteria and is currently under the care of a rheumatologist, nephrologist, or other physician regarding SLE care
• Be willing and able to comply with all the study-related procedures

Exclusion criteria

• Pregnant or planning pregnancy within the duration of the interventional study.
• Currently following a vegetarian/vegan diet.
• Allergy/sensitivity to gluten, soy, or cow's milk.
• Self-disclosure of lactose intolerance
• Inability to comply with the study procedures.
• Baseline dietary fiber intake > 30 g/day
• MEDAS score at baseline > 9
• Baseline consumption of > 2 servings per day of fermented foods

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Mediterranean diet

Experimental group

Description:

Participants will receive diet education on adherence to a Mediterranean dietary pattern.

Treatment:

Other: Mediterranean Dietary Pattern

Fermented food

Experimental group

Description:

Participants will receive diet education on adherence to a high fermented food dietary pattern.

Treatment:

Other: High Fermented Food Dietary Pattern