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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Other: Mediterranean Dietary Pattern; Other: High Fermented Food Dietary Pattern

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wendy J Dahl, PhD; Phone Number: 3522943707; Email: wdahl@ufl.edu
• Study Contact Backup: Name: Kaylan Hebert, BS; Phone Number: 3522639136; Email: ufnutrition@ifas.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Recruiting
      • University of Florida/UF Health
      • Contact: Wendy J Dahl, PhD; Phone Number: 352-294-3707; Email: wdahl@ufl.edu
      • Contact: Study Coordinator; Phone Number: 3522639136

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mediterranean diet; Participants will receive diet education on adherence to a Mediterranean dietary pattern.	Other: Mediterranean 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.
Experimental: Fermented food; Participants will receive diet education on adherence to a high fermented food dietary pattern.	Other: High 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Anticipated): May 4, 2025
• Study Completion (Anticipated): May 4, 2025

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Inflammation; Lupus; SLE; Mediterranean diet; Fermented food
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Inflammation
• Other Study ID Numbers: IRB202200703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No