Menu
Recruiting NCT05559463

Effect of Anti-inflammatory (ITIS) Diet in Knee Osteoarthritis

No phase Interventional Osteoarthritis, Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ITIS diet.
Who it may be relevant to
Registry conditions: Osteoarthritis, Knee. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Detailed description

The investigators would like to evaluate how inflammation occurs in the joints of subjects with osteoarthritis, and identify molecules and bacteria that can predict whether a patients with knee osteoarthritis will have more or less pain . 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.

Interventions

  • Dietary supplement ITIS diet
    anti-inflammatory (ITIS) diet for 28 days

Primary outcome measures

  • Change of baseline pain measured by visual analogue scale (0-10) after 28 days [Time frame: 28 days]

Eligibility criteria

Inclusion criteria

  • patients diagnosed of Knee Ostoeaarthritis
  • without changes in treatment in the last 3 months

Exclusion criteria

  • food allergies
  • pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • UCSD — La Jolla

Publications

  • 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. do PMID 40944120

Identifiers

NCT: NCT05559463 · 161474_2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗