TerminatedNot Applicable

Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation in Lupus

Stopped: Lack of funding to continue.

United States5 participantsStarted 2022-03-22

Plain-language summary

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).

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \> 18 years of age * Able to provide informed consent and undertake study questionnaire completion in English * Meets SLE diagnostic criteria and is currently under the care of a rheumatologist, nephrologist, or other physician regarding SLE care * Be willing and able to comply with all the study-related procedures Exclusion Criteria: * Pregnant or planning pregnancy within the duration of the interventional study. * Currently following a vegetarian/vegan diet. * Allergy/sensitivity to gluten, soy, or cow's milk. * Self-disclosure of lactose intolerance * Inability to comply with the study procedures. * Baseline dietary fiber intake \> 30 g/day * MEDAS score at baseline \> 9 * Baseline consumption of \> 2 servings per day of fermented foods

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adherence - Mediterranean Diet

Timeframe: baseline, month 1, 2 and 3

Adherence - Fermented Food Diet

Timeframe: baseline, month 1, 2, and 3

Trial details

NCT IDNCT05379725

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-01

View on ClinicalTrials.gov More Lupus Erythematosus, Systemic trials

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.