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Dietary Intervention

Mediterranean vs. Fermented Food Diets for Lupus

N/A
Waitlist Available
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age
Meets SLE diagnostic criteria and is currently under the care of a rheumatologist, nephrologist, or other physician regarding SLE care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 1, 2 and 3
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare how well two different diets work for people with Lupus.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include digestive discomfort as the body adjusts to new eating patterns. Specific side effects will depend on individual tolerances to components of the Mediterranean or high-fermented-food diets.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with lupus and am seeing a specialist for it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 1, 2 and 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 1, 2 and 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence - Fermented Food Diet
Adherence - Mediterranean Diet
Secondary study objectives
Cytokine profile
Diet Quality
ESR
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,400 Previous Clinical Trials
767,069 Total Patients Enrolled

Media Library

High Fermented Food Dietary Pattern (Dietary Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05379725 — N/A
Systemic Lupus Erythematosus Research Study Groups: Mediterranean diet, Fermented food
Systemic Lupus Erythematosus Clinical Trial 2023: High Fermented Food Dietary Pattern Highlights & Side Effects. Trial Name: NCT05379725 — N/A
High Fermented Food Dietary Pattern (Dietary Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05379725 — N/A
~6 spots leftby May 2025
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