Rheumatoid ArthritisNCT04999683
Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis
A study testing ITIS diet in people with Rheumatoid Arthritis and Osteoarthritis, 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 rheumatoid arthritis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis
- What is being tested?
- ITIS diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 diagnosed of rheumatoid arthritis
- without changes in treatment in the last 3 months
Who cannot join
- food allergies
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
to study the effect of anti-inflammatory diet on clinical and biological outcomes in rheumatoid arthritis
Read the detailed description
The investigators would like to evaluate how inflammation occurs in the joints of subjects with arthritis, and identify molecules and bacteria that can predict whether a rheumatic subject will flare. Blood, urine and stool will be evaluated in the laboratory and compared to their own samples after changes in diet. This is an exploratory study, which is meant to gather preliminary data about the quick effects of changes in diet and treatment on molecules in blood/urine and bacteria in stools. These studies can provide clues to the cause of disease and might ultimately lead to new therapies.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis
- Being tested
- ITIS diet
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITIS dietDietary supplement
anti-inflammatory diet for 14 days
| Study group | Role | What they receive |
|---|---|---|
| ITIS diet | Experimental | anti-inflammatory (ITIS) diet for 14 days Receives: Dietary Supplement: ITIS diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of baseline pain measured by visual analogue scale (0-10) after two weeks of ITIS diet
Change of baseline pain measured by visual analogue scale after two weeks of ITIS diet, being 0 no pain, and 10 worse pain
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Sep 2018
- Primary completion1 Sep 2021
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999683
- Sponsor's protocol ID
- 161474
- Status last verified
- May 2022
- First submitted
- 2 Aug 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sala-Climent M, Lal E, Cedola F, Alharthi M, Fernandez-Bustamante M, Agustin-Perez M, Singh A, Choi SI, Rivera T, Nguyen K, Lee S, Golshan S, Holt T, Quehenberger O, Coras R, Guma M. Oxylipin serum profile changes in response to an open-label anti-inflammatory dietary intervention. Clin Nutr ESPEN. 2025 Aug;68:389-402. doi: 10.1016/j.clnesp.2025.05.027. Epub 2025 May 23.
PubMed 40414498
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04999683
- Acronym / sponsor ID
- 161474
- Conditions
- Rheumatoid Arthritis, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 11 Aug 2021 (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 rheumatoid arthritis
Detailed description
The investigators would like to evaluate how inflammation occurs in the joints of subjects with arthritis, and identify molecules and bacteria that can predict whether a rheumatic subject will flare. Blood, urine and stool will be evaluated in the laboratory and compared to their own samples after changes in diet. This is an exploratory study, which is meant to gather preliminary data about the quick effects of changes in diet and treatment on molecules in blood/urine and bacteria in stools. These studies can provide clues to the cause of disease and might ultimately lead to new therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ITIS diet | Experimental | Dietary Supplement: ITIS dietanti-inflammatory (ITIS) diet for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients diagnosed of rheumatoid arthritis
- without changes in treatment in the last 3 months
Key exclusion criteria (2 listed)
- food allergies
- pregnancy
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 |
|---|---|---|
| ITIS dietanti-inflammatory diet for 14 days | Dietary supplement | ITIS diet |
Primary outcome
Change of baseline pain measured by visual analogue scale (0-10) after two weeks of ITIS diet
Time frame: 2 weeks
Change of baseline pain measured by visual analogue scale after two weeks of ITIS diet, being 0 no pain, and 10 worse pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 40414498Sala-Climent M, Lal E, Cedola F, Alharthi M, Fernandez-Bustamante M, Agustin-Perez M, Singh A, Choi SI, Rivera T, Nguyen K, Lee S, Golshan S, Holt T, Quehenberger O, Coras R, Guma M. Oxylipin serum profile changes in response to an open-label anti-inflammatory dietary intervention. Clin Nutr ESPEN. 2025 Aug;68:389-402. doi: 10.1016/j.clnesp.2025.05.027. Epub 2025 May 23.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ITIS diet in people with Rheumatoid Arthritis and Osteoarthritis, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 1 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of baseline pain measured by visual analogue scale (0-10) after two weeks of ITIS diet (time frame: 2 weeks). 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 NCT04999683, which also lists 1 linked publication.
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 1 Nov 2022.