Systemic Lupus Erthematosus (SLE)NCT07713940
Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous
A study testing anti-inflammatory diet in people with Systemic Lupus Erthematosus (SLE), run by University of California, San Diego at 1 site in United States.
Trial summary
To study the effect of anti-inflammatory diet on clinical and biological outcomes in lupus Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erthematosus (SLE)
- What is being tested?
- anti-inflammatory diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Altman Clinical Translational Research Insitute (UC San Diego)
La Jolla, California, 92097
Monica Guma, MD, PhD, 858-, mguma@health.ucsd.edu
Monica Guma, MD.PhD
About this study
To study the effect of anti-inflammatory diet on clinical and biological outcomes in lupus
Read the 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.
- Conditions
- Systemic Lupus Erthematosus (SLE)
- Being tested
- anti-inflammatory diet
- Keywords
- lupus, diet, anti-inflammatory diet, mediterranean diet, cellcept, mycophenalate, microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-inflammatory dietDietary supplement
anti-inflammatory diet for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| anti-inflammatory diet | Experimental | anti-inflammatory diet Receives: Dietary Supplement: anti-inflammatory diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Jul 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus Erthematosus (SLE)Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- anti-inflammatory diet for 6 weeks
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Guma, University of California, San Diego
- Investigators
- Monica Guma, MD, PhD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713940
- Sponsor's protocol ID
- 161474_3
- Other IDs
- IDEAL
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32025586Coras 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.
PubMed 35802808Sala-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.
PubMed 40944120
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous
- ClinicalTrials.gov ID
- NCT07713940
- Acronym / sponsor ID
- 161474_3
- Conditions
- Systemic Lupus Erthematosus (SLE)
- Keywords
- lupus, diet, anti-inflammatory diet, mediterranean diet, cellcept, mycophenalate, microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- anti-inflammatory diet for 6 weeks
| Arm | Type | Receives |
|---|---|---|
| anti-inflammatory diet | Experimental | Dietary Supplement: anti-inflammatory dietanti-inflammatory diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-inflammatory dietanti-inflammatory diet for 6 weeks | Dietary supplement | anti-inflammatory diet |
Primary outcome
PROMIS pain interference
Time frame: 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
Time frame: 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.
1 secondary outcome
PROMIS physical function
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 32025586Bustamante 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.
- Background: PubMed 35802808Coras 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.
- Background: PubMed 40944120Sala-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monica Guma, MD, PhD principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti-inflammatory diet in people with Systemic Lupus Erthematosus (SLE), run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Guma, MD, PhD (858-822-6523, mguma@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS pain interference (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07713940, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.