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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lupus Erythematosus, Systemic

Intervention / Treatment
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* Other: Mediterranean Dietary Pattern
* Other: High Fermented Food Dietary Pattern


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean diet<br>Participants will receive diet education on adherence to a Mediterranean dietary pattern. | Other: Mediterranean Dietary Pattern<br>* The Mediterranean dietary pattern includes whole or minimally processed foods with a high intake of vegetables, fruits, whole grains, fish, and olive oil.<br>|
| Experimental: Fermented food<br>Participants will receive diet education on adherence to a high fermented food dietary pattern. | Other: High Fermented Food Dietary Pattern<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet Quality | Healthy Eating Index 2015 score (0 minimum to 100 maximum). Higher values indicate better diet quality. | 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. | baseline, month 3 | 
| ESR | Erythrocyte sedimentation rate | baseline, month 3 | 
| hsCRP | high-sensitivity C-reactive protein | baseline, month 3 | 
| anti-dsDNA | Anti-double stranded DNA | baseline, month 3 | 
| Cytokine profile | Cytokines profile e.g., interleukin-18 (IL-18), tumor necrosis factor (TNF), IL-6, IL-2, IL-10 | baseline, month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLE, Lupus, Mediterranean diet, Fermented food, Inflammation