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Clinical Trials/NCT05559463
NCT05559463
Recruiting
Not Applicable

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

University of California, San Diego1 site in 1 country30 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
University of California, San Diego
Enrollment
30
Locations
1
Primary Endpoint
Change of baseline pain measured by visual analogue scale (0-10) after 28 days
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
October 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Monica Guma

Associate Professor of Medicine

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • food allergies
  • pregnancy

Outcomes

Primary Outcomes

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

Time Frame: 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

Study Sites (1)

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