Mediterranean vs. Fermented Food Diets for Lupus

Overseen By Wendy J Dahl, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Pregnancy, Vegetarian/vegan, Gluten/soy/cow's milk allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for adults over 18 with Systemic Lupus Erythematosus (SLE) who are being treated by a specialist. Participants must speak English, be able to consent, and follow the study's procedures. It excludes pregnant individuals or those planning pregnancy, people with certain food allergies or intolerances, vegetarians/vegans, and those already consuming high levels of fermented foods or dietary fiber.

Inclusion Criteria

Able to provide informed consent and undertake study questionnaire completion in English

I am 18 years old or older.

Be willing and able to comply with all the study-related procedures

Exclusion Criteria

Self-disclosure of lactose intolerance

Baseline dietary fiber intake > 30 g/day

MEDAS score at baseline > 9

Treatment Details

Interventions

• High Fermented Food Dietary Pattern
• Mediterranean Dietary Pattern

Trial Overview The study tests how well participants with SLE can stick to two diets: the Mediterranean diet and a diet rich in fermented foods. This randomized controlled trial lasts four months and aims to see if these diets can reduce inflammation associated with lupus.

Participant Groups

Group I: Mediterranean diet Experimental Treatment 1 Intervention

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

Group II: Fermented food Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+