Targeted Microbial Shifts and Metabolite Profiles Were Associated with Clinical Response to an Anti-Inflammatory Diet in Osteoarthritis.
Marta Sala-Climent, Kevin Bu, Roxana Coras...
https://pubmed.ncbi.nlm.nih.gov/40944120/Actively Recruiting
Led by University of California, San Diego · Updated on 2026-07-20
36
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating the effects of an anti-inflammatory diet on adults with Systemic Lupus Erythematosus SLE. The study aims to understand how inflammation and related molecules, as well as gut bacteria, change in people with lupus. This exploratory trial is designed to generate early data on how dietary changes might influence blood biomarkers and the gut microbiome, potentially offering insights into lupus mechanisms and future treatments. Participants will follow an anti-inflammatory diet for six weeks. Blood and stool samples will be collected and analyzed to compare biological changes before and after the dietary intervention. The study focuses on short-term effects and does not involve other treatment comparisons. During the six-week period, participants will be assessed for changes in symptoms such as pain interference and fatigue using the PROMIS scales. Researchers will also evaluate physical function. Participants will provide biological samples for laboratory analysis, and their adherence to the diet will be monitored. The entire study participation lasts at least six weeks, with measurements taken to understand the diets impact on lupus symptoms and biomarkers.
CONDITIONS
Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous
M
Monica Guma, MD, PhD
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University of California, San Diego
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Anti-inflammatory diet (6 weeks, trial) | Current standard care (no structured diet intervention, external context) |
|---|---|---|
| What it is | A structured anti-inflammatory diet prescribed and followed for 6 weeks in adults with SLE already on Cellcept or Myfortic. | Usual clinical management for SLE, including medications such as Cellcept or Myfortic, without an added structured anti-inflammatory diet. |
| Primary use | Investigational: evaluated for its impact on pain interference, fatigue, and physical function in SLE. | Management of disease signs and symptoms with immune-modulating drugs and clinical monitoring. |
| How it is given or performed | Participants follow a prescribed anti-inflammatory diet plan for 6 weeks while continuing their baseline SLE therapy. | Standard medication regimen (such as Cellcept or Myfortic) with no added structured dietary regimen. |
| Evidence status | Currently under clinical investigation in SLE. External studies in related autoimmune conditions (such as RA and osteoarthritis) have shown possible benefits, but SLE-specific results are not yet available. | Established medications are supported by extensive clinical data for SLE management, but dietary modifications do not have specific, guideline-supported evidence for reducing pain or fatigue in SLE. |
| Important limitations | Single-group trial design without a randomized control group; dietary intervention adherence and longer-term effects in SLE are not yet established. | Current standard care may not address all symptoms such as persistent fatigue or pain, and does not incorporate an evidence-based dietary approach. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants follow an anti-inflammatory diet for six weeks while providing blood and stool samples for analysis.
Regular assessments including symptom questionnaires and sample collection
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/40944120/Roxana Coras, Cameron Martino, Julia M Gauglitz...
https://pubmed.ncbi.nlm.nih.gov/35802808/Marta F Bustamante, Meritxall Agustín-Perez, Francesca Cedola...
https://pubmed.ncbi.nlm.nih.gov/32025586/University of California, San Diego
Lead Sponsor