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

Sponsor

University of Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT05379725

Collaborator

(none)

Enrollment

Location

Arms

33.1

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus, Systemic	Other: Mediterranean Dietary Pattern Other: High Fermented Food Dietary Pattern	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation and Disease Activity in Systemic Lupus Erythematosus

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

May 4, 2025

Anticipated Study Completion Date :

May 4, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mediterranean diet Participants will receive diet education on adherence to a Mediterranean dietary pattern.	Other: 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.
Experimental: Fermented food Participants will receive diet education on adherence to a high fermented food dietary pattern.	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.

Arm

Intervention/Treatment

Experimental: Mediterranean diet

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

Other: 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.

Experimental: Fermented food

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

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.

Outcome Measures

Primary Outcome Measures

Adherence - Mediterranean Diet [baseline, month 1, 2 and 3]
Percent of participants achieving 'good to very good adherence') as assessed by the 14-day Mediterranean diet questionnaire (MEDAS) score
Adherence - Fermented Food Diet [baseline, month 1, 2, and 3]
Percent of participants achieving > 5 servings of fermented foods per day

Secondary Outcome Measures

Diet Quality [baseline, month 3]
Healthy Eating Index 2015 score (0 minimum to 100 maximum). Higher values indicate better diet quality.
Systemic Lupus Erythematosus Disease Activity [baseline, month 3]
Systemic Lupus Erythematosus disease activity using the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score (0 minimum and 105 maximum, with higher scores representing higher disease activity.
ESR [baseline, month 3]
Erythrocyte sedimentation rate
hsCRP [baseline, month 3]
high-sensitivity C-reactive protein
anti-dsDNA [baseline, month 3]
Anti-double stranded DNA
Cytokine profile [baseline, month 3]
Cytokines profile e.g., interleukin-18 (IL-18), tumor necrosis factor (TNF), IL-6, IL-2, IL-10

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Able to provide informed consent and undertake study questionnaire completion in English.
Meet SLE diagnostic criteria.
Be willing and able to comply with all the study-related procedures.
Stable immunosuppression regimen not expected to change over the course of the study.