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

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ITIS diet
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • food allergies
  • pregnancy

Sites / Locations

  • UCSDRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ITIS diet

Arm Description

anti-inflammatory (ITIS) diet for 28 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 25, 2022
Last Updated
October 6, 2023
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT05559463
Brief Title
Effect of Anti-inflammatory (ITIS) Diet in Knee Osteoarthritis
Official Title
Effect of Anti-inflammatory (ITIS) Diet in Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ITIS diet
Arm Type
Experimental
Arm Description
anti-inflammatory (ITIS) diet for 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
ITIS diet
Intervention Description
anti-inflammatory (ITIS) diet for 28 days
Primary Outcome Measure Information:
Title
Change of baseline pain measured by visual analogue scale (0-10) after 28 days
Description
Change of baseline pain measured by visual analogue scale (0-10) after 28 days, being 0 no pain, and 10 the worse outcome
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients diagnosed of Knee Ostoeaarthritis without changes in treatment in the last 3 months Exclusion Criteria: food allergies pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Guma, MD, PhD
Phone
8588226523
Email
mguma@ucsd.edu
Facility Information:
Facility Name
UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Guma, MD
Email
mguma@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Monica Guma, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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