NCT05559463

Brief Summary

To study the effect of anti-inflammatory diet on clinical and biological outcomes in patients with knee osteoarthritis

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Oct 2021

Longer than P75 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 Progress93%
Oct 2021Oct 2026

Study Start

First participant enrolled

October 1, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

4.3 years

First QC Date

September 25, 2022

Last Update Submit

May 7, 2024

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • Change of baseline pain measured by visual analogue scale (0-10) after 28 days

    Change of baseline pain measured by visual analogue scale (0-10) after 28 days, being 0 no pain, and 10 the worse outcome

    28 days

Study Arms (1)

ITIS diet

EXPERIMENTAL

anti-inflammatory (ITIS) diet for 28 days

Dietary Supplement: ITIS diet

Interventions

ITIS dietDIETARY_SUPPLEMENT

anti-inflammatory (ITIS) diet for 28 days

ITIS diet

Eligibility Criteria

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

You may qualify if:

  • patients diagnosed of Knee Ostoeaarthritis
  • 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

RECRUITING

Related Publications (1)

  • 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: 40944120DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Monica Guma, MD, PhD

CONTACT

8588226523mguma@ucsd.edu

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

September 25, 2022

First Posted

September 29, 2022

Study Start

October 1, 2021

Primary Completion

January 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)