40 Participants Needed

Mediterranean vs. Fermented Food Diets for Lupus

KH
WJ
Overseen ByWendy J Dahl, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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
See 5 more

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
2Treatment groups
Experimental Treatment
Group I: Mediterranean dietExperimental Treatment1 Intervention
Participants will receive diet education on adherence to a Mediterranean dietary pattern.
Group II: Fermented foodExperimental Treatment1 Intervention
Participants will receive diet education on adherence to a high fermented food dietary pattern.

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Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+
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