Lupus Erythematosus, Systemic
Conditions
Keywords
SLE, Lupus, Mediterranean diet, Fermented food, Inflammation
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.
Interventions
OTHERMediterranean 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.
OTHERHigh 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.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| ESR | baseline, month 3 | Erythrocyte sedimentation rate |
| hsCRP | baseline, month 3 | high-sensitivity C-reactive protein |
| Diet Quality | baseline, month 3 | Healthy Eating Index 2015 score (0 minimum to 100 maximum). Higher values indicate better diet quality. |
| Cytokine profile | baseline, month 3 | Cytokines profile e.g., interleukin-18 (IL-18), tumor necrosis factor (TNF), IL-6, IL-2, IL-10 |
| anti-dsDNA | baseline, month 3 | Anti-double stranded DNA |
| 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. |
Countries
United States
Outcome results
None listed