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NCT05559463 Clinical Trial

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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05559463
Other study ID # 161474_2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date October 1, 2026

Study information
Verified date May 2024
Source University of California, San Diego
Contact Monica Guma, MD, PhD
Phone 8588226523
Email mguma@ucsd.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date October 1, 2026
Est. primary completion date January 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients diagnosed of Knee Ostoeaarthritis - without changes in treatment in the last 3 months Exclusion Criteria: - food allergies - pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States UCSD La Jolla California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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