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

NCT ID: NCT05379725

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-22
• Study Completion Date: 2025-03-01

Brief Summary

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).

Detailed 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.

Conditions

Lupus Erythematosus, Systemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Mediterranean diet

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

Group Type: EXPERIMENTAL

Mediterranean Dietary Pattern

Intervention Type: OTHER

The Mediterranean dietary pattern includes whole or minimally processed foods with a high intake of vegetables, fruits, whole grains, fish, and olive oil.

Fermented food

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

Group Type: EXPERIMENTAL

High Fermented Food Dietary Pattern

Intervention Type: OTHER

Fermented foods such as yogurt, kefir, fermented cottage cheese, fermented vegetables, vegetable brine drinks, kombucha, other fermented non-alcoholic drinks, and other foods will be recommended.

Interventions

Mediterranean Dietary Pattern

The Mediterranean dietary pattern includes whole or minimally processed foods with a high intake of vegetables, fruits, whole grains, fish, and olive oil.

Intervention Type: OTHER

High Fermented Food Dietary Pattern

Fermented foods such as yogurt, kefir, fermented cottage cheese, fermented vegetables, vegetable brine drinks, kombucha, other fermented non-alcoholic drinks, and other foods will be recommended.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Florida/UF Health

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB202200703

Identifier Type: -

Identifier Source: org_study_id