NCT04999683

Brief Summary

to study the effect of anti-inflammatory diet on clinical and biological outcomes in rheumatoid arthritis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 1, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

November 1, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

August 2, 2021

Last Update Submit

October 31, 2022

Conditions

Rheumatoid ArthritisOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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

    2 weeks

Study Arms (1)

ITIS diet

EXPERIMENTAL

anti-inflammatory (ITIS) diet for 14 days

Dietary Supplement: ITIS diet

Interventions

ITIS dietDIETARY_SUPPLEMENT

anti-inflammatory diet for 14 days

ITIS diet

Eligibility Criteria

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

You may qualify if:

  • patients diagnosed of rheumatoid arthritis
  • without changes in treatment in the last 3 months

You may not qualify if:

  • food allergies
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD

La Jolla, California, 92093, United States

Location

Related Publications (1)

  • 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.

    PMID: 40414498DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

August 2, 2021

First Posted

August 11, 2021

Study Start

September 1, 2018

Primary Completion

September 1, 2021

Study Completion

September 1, 2022

Last Updated

November 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)