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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
5
The Mediterranean dietary pattern includes whole or minimally processed foods with a high intake of vegetables, fruits, whole grains, fish, and olive oil.
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.
University of Florida/UF Health
Gainesville, Florida, United States
Adherence - Mediterranean Diet
Percent of participants achieving 'good to very good adherence') as assessed by the 14-day Mediterranean diet questionnaire (MEDAS) score
Time frame: baseline, month 1, 2 and 3
Adherence - Fermented Food Diet
Percent of participants achieving \> 5 servings of fermented foods per day
Time frame: baseline, month 1, 2, and 3
Diet Quality
Healthy Eating Index 2015 score (0 minimum to 100 maximum). Higher values indicate better diet quality.
Time frame: baseline, month 3
Systemic Lupus Erythematosus Disease Activity
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.
Time frame: baseline, month 3
ESR
Erythrocyte sedimentation rate
Time frame: baseline, month 3
hsCRP
high-sensitivity C-reactive protein
Time frame: baseline, month 3
anti-dsDNA
Anti-double stranded DNA
Time frame: baseline, month 3
Cytokine profile
Cytokines profile e.g., interleukin-18 (IL-18), tumor necrosis factor (TNF), IL-6, IL-2, IL-10
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Time frame: baseline, month 3