Health TrialsbyHealthPanel

Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous

ConditionSystemic Lupus Erthematosus (SLE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego

About this trial

To study the effect of anti-inflammatory diet on clinical and biological outcomes in lupus

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients who meet the 2019 EULAR/ACR Classification Criteria for SLE

patients who are on Cellcept or Myfortic for at least 3 months prior to screening

patients with a score of ≥55 on the Patient Reported Outcomes Measurement Information System (PROMIS) Pain interference scale.

Disqualifiers

pregnant or lactating patients,

patients with food allergy

patients on antibiotics within 4 weeks of the screening

patients that change the SLE therapy during the length of the study (12 weeks).

Trial design

Design model

Single group

Treatments tested in this trial

  • anti-inflammatory diet

    Dietary supplement

    anti-inflammatory diet for 6 weeks

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: anti-inflammatory dietExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PROMIS pain interference

PROMIS Pain Interference: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference. Scores are typically reported as T-scores ranging from approximately 20 to 80 (theoretical range varies by item bank). Higher scores indicate worse outcomes, reflecting greater pain interference with daily activities.

Time frame
6 weeks
2

PROMIS fatigue

PROMIS Fatigue: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue. Scores are typically reported as T-scores ranging from approximately 20 to 80. Higher scores indicate worse outcomes, reflecting greater fatigue.

Time frame
6 weeks

Secondary outcomes

1

PROMIS physical function

PROMIS Physical Function: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function. Scores are typically reported as T-scores ranging from approximately 20 to 80. Higher scores indicate better outcomes, reflecting better physical functioning.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

Source ClinicalTrials.gov
Apply now