NCT07713940

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
36mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026Jul 2029

Study Start

First participant enrolled

July 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 5, 2026

Last Update Submit

July 14, 2026

Conditions

Systemic Lupus Erthematosus (SLE)

Keywords

lupusdietanti-inflammatory dietmediterranean dietcellceptmycophenalatemicrobiome

Outcome Measures

Primary Outcomes (2)

  • 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.

    6 weeks

  • 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.

    6 weeks

Secondary Outcomes (1)

  • PROMIS physical function

    6 weeks

Study Arms (1)

anti-inflammatory diet

EXPERIMENTAL

anti-inflammatory diet

Dietary Supplement: anti-inflammatory diet

Interventions

anti-inflammatory dietDIETARY_SUPPLEMENT

anti-inflammatory diet for 6 weeks

anti-inflammatory diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altman Clinical Translational Research Insitute (UC San Diego)

La Jolla, California, 92097, United States

RECRUITING

Related Publications (3)

  • Bustamante MF, Agustin-Perez M, Cedola F, Coras R, Narasimhan R, Golshan S, Guma M. Design of an anti-inflammatory diet (ITIS diet) for patients with rheumatoid arthritis. Contemp Clin Trials Commun. 2020 Jan 21;17:100524. doi: 10.1016/j.conctc.2020.100524. eCollection 2020 Mar.

    PMID: 32025586BACKGROUND

  • Coras R, Martino C, Gauglitz JM, Cedola F, Tripathi A, Jarmusch AK, Alharthi M, Fernandez-Bustamante M, Agustin-Perez M, Singh A, Choi SI, Rivera T, Nguyen K, Shekhtman T, Holt T, Lee S, Golshan S, Dorrestein PC, Knight R, Guma M. Baseline microbiome and metabolome are associated with response to ITIS diet in an exploratory trial in patients with rheumatoid arthritis. Clin Transl Med. 2022 Jul;12(7):e959. doi: 10.1002/ctm2.959. No abstract available.

    PMID: 35802808BACKGROUND

  • Sala-Climent M, Bu K, Coras R, Cedeno M, Zuffa S, Murillo-Saich J, Mannochio-Russo H, Allaband C, Hose MK, Quan A, Choi SI, Nguyen K, Golshan S, Blank RB, Holt T, Lane NE, Knight R, Scher J, Dorrestein P, Clemente J, Guma M. Targeted Microbial Shifts and Metabolite Profiles Were Associated with Clinical Response to an Anti-Inflammatory Diet in Osteoarthritis. Nutrients. 2025 Aug 22;17(17):2729. doi: 10.3390/nu17172729.

    PMID: 40944120BACKGROUND

Study Officials

  • Monica Guma, MD, PhD

    UC San Diego

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Guma, MD, PhD

CONTACT

858-822-6523mguma@health.ucsd.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: anti-inflammatory diet for 6 weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 5, 2026

First Posted

July 20, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2029

Last Updated

July 20, 2026

Record last verified: 2026-07

Locations

US(1)