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

NCT05379725 | Terminated

• 1 other identifier: IRB202200703
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Lupus Erythematosus, Systemic

Keywords

SLE; Lupus; Mediterranean diet; Fermented food; Inflammation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Diet Quality

  baseline, month 3

• Systemic Lupus Erythematosus Disease Activity

  baseline, month 3

• ESR

  baseline, month 3

• hsCRP

  baseline, month 3

• anti-dsDNA

  baseline, month 3

Study Arms (2)

Mediterranean diet

EXPERIMENTAL

Participants will receive diet education on adherence to a Mediterranean dietary pattern.

Other: Mediterranean Dietary Pattern

Fermented food

EXPERIMENTAL

Participants will receive diet education on adherence to a high fermented food dietary pattern.

Other: High Fermented Food Dietary Pattern

Interventions

Mediterranean Dietary Pattern OTHER

The Mediterranean dietary pattern includes whole or minimally processed foods with a high intake of vegetables, fruits, whole grains, fish, and olive oil.

Mediterranean diet

High Fermented Food Dietary Pattern OTHER

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.

Fermented food

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida/UF Health

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Inflammation

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 18, 2022
• Study Start: March 22, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)