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

Not Applicable

Active, not recruiting

• Conditions: Lupus Erythematosus, Systemic
• Interventions: Other: Mediterranean Dietary Pattern; Other: High Fermented Food Dietary Pattern

• Registration Number: NCT05379725
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-13
• Study First Posted: 2022-05-18
• Study Start: 2022-07-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29
• Primary Completion: 2025-05-04
• Study Completion: 2025-05-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediterranean diet	Mediterranean Dietary Pattern	Participants will receive diet education on adherence to a Mediterranean dietary pattern.
Fermented food	High Fermented Food Dietary Pattern	Participants will receive diet education on adherence to a high fermented food dietary pattern.

Primary Outcome Measures

Name	Time	Method
Adherence - Fermented Food Diet	baseline, month 1, 2, and 3	Percent of participants achieving \> 5 servings of fermented foods per day
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

Secondary Outcome Measures

Name	Time	Method
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
Diet Quality	baseline, month 3	Healthy Eating Index 2015 score (0 minimum to 100 maximum). Higher values indicate better diet quality.
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

Trial Locations

Locations (1)

University of Florida/UF Health; 🇺🇸 Gainesville, Florida, United States