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

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

I have been diagnosed with lupus and am seeing a specialist for it.

Exclusion Criteria

Self-disclosure of lactose intolerance

Baseline dietary fiber intake > 30 g/day

MEDAS score at baseline > 9

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants follow their usual diet for 1 month to establish baseline dietary habits

1 month

Monthly online questionnaires

Intervention

Participants adhere to either a Mediterranean or high-fermented-food diet for 3 months

3 months

Monthly online questionnaires and blood sample collection at the end of the intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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+