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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

Study 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.Check my eligibility
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.See study design
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

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

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
1,340 Previous Clinical Trials
715,665 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to participate in this clinical trial?

"This clinical investigation is seeking 40 individuals, aged 18 to 100, who have been diagnosed with Libman-Sacks disease. Aside from this requirement, they must be capable of providing informed consent and responding to study questionnaires in English, meet the diagnostic criteria for SLE while currently under treatment by a rheumatologist or other medical specialist related to SLE care, as well as being willing and able to fulfill all study procedures."

Answered by AI

How extensive is the current sample size for this research endeavor?

"Affirmative. Information posted on the clinicaltrials.gov website indicates that this research endeavour, which was initially advertised on July 22nd 2022 is actively recruiting patients. The study requires 40 participants to be sourced from one medical centre."

Answered by AI

Are there any opportunities currently available for participants in this research?

"Clinicialtrials.gov reveals that this clinical trial is still enrolling participants, with the initial post on July 22nd 2022 followed by an update to the listing on October 13th 2022."

Answered by AI

Does this clinical exploration have age restrictions?

"Applicants that meet the criteria for inclusion in this trial must be between 18 to 100 years old. There are 46 separate studies dedicated exclusively to patients below 18 and 370 specifically targeting individuals over 65."

Answered by AI

What are the principal goals of this experiment?

"This clinical trial will primarily evaluate adherence to a fermented food diet over the first three months of treatment. Secondary outcomes include hsCRP, SLEDAI-2K score and Healthy Eating Index 2015 scores; all designed to assess diet quality while taking into consideration systemic lupus erythematosus disease activity levels."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation in Lupus
2022. "Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation in Lupus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05379725.
All > Systemic Lupus Erythematosus > Lupus
~15 spots leftby May 2025
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