Clinical trial NCT05379725: Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation in Lupus
Official title: Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation and Disease Activity in Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lupus Erythematosus, Systemic
Keywords: SLE
Lupus
Mediterranean diet
Fermented food
Inflammation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Adherence - Mediterranean Diet
timeFrame: baseline, month 1, 2 and 3
measure: Adherence - Fermented Food Diet
timeFrame: baseline, month 1, 2, and 3
Secondary outcomes:
measure: Diet Quality
timeFrame: baseline, month 3
measure: Systemic Lupus Erythematosus Disease Activity
timeFrame: baseline, month 3
measure: ESR
timeFrame: baseline, month 3
measure: hsCRP
timeFrame: baseline, month 3
measure: anti-dsDNA
timeFrame: baseline, month 3
measure: Cytokine profile
timeFrame: baseline, month 3
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida/UF Health
state: Florida
Study officials:
References: