Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07713940

Enrollment

Registered

2026-07-20

Start date

2026-07-01

Completion date

2029-07-01

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erthematosus (SLE)

Keywords

lupus, diet, anti-inflammatory diet, mediterranean diet, cellcept, mycophenalate, microbiome

Brief summary

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

Detailed description

The investigators aim to evaluate how inflammation changes in individuals with lupus and to identify molecules and gut bacteria that may help predict disease flares. Blood and stool samples will be analyzed in the laboratory and compared with samples collected from the same participants following dietary changes. This is an exploratory study designed to generate preliminary data on the short-term effects of dietary changes and treatment on blood biomarkers and the gut microbiome. The findings may provide insights into the mechanisms underlying lupus and could ultimately contribute to the development of new therapeutic approaches.

Interventions

DIETARY_SUPPLEMENTanti-inflammatory diet

anti-inflammatory diet for 6 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

anti-inflammatory diet for 6 weeks

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

Measure	Time frame	Description
PROMIS pain interference	6 weeks	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.
PROMIS fatigue	6 weeks	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.

Secondary

Measure	Time frame	Description
PROMIS physical function	6 weeks	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.

Countries

United States

Contacts

CONTACTMonica Guma, MD, PhD

mguma@health.ucsd.edu858-822-6523

PRINCIPAL_INVESTIGATORMonica Guma, MD, PhD

UC San Diego

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026