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Effect of Anti-inflammatory Diet in Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anti-inflammatory Diet
Healthy Diet
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis, Knee

Eligibility Criteria

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

Inclusion Criteria: Unilateral radiographic symptomatic KOA No changes in therapy during the previous 3 months Interested in dietary intervention and able to provide consent and attend follow-up visits Exclusion Criteria: Previous knee surgery Severe radiographic disease (KL grade 4) Rheumatoid Arthritis Any Abnormal blood values in the comprehensive metabolic panel test at screen (Abnormality will be defined based on standard reference ranges) Use of corticosteroids and/or intra-articular injections during the preceding 3 months Use of fish oils and glucosamine Participation in a weight loss program in the preceding 6 months Recent changes in physical activity levels Regular smoking Patients with food allergies Patient with other medical conditions that will impair the ability to participate in a nutritional study Plan to change systemic therapy Patients unwilling to change dietary habits

Sites / Locations

  • University of CaliforniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm_1

Arm_2

Arm Description

Anti-inflammatory Diet

Healthy Diet

Outcomes

Primary Outcome Measures

Change in Knee Osteoarthritis Pain
The Western Ontario and McMaster Universities Osteoarthritis Index, known as the WOMAC score, is a validated questionnaire used for evaluating pain, stiffness, and physical function in individuals with knee or hip osteoarthritis. A minimum score of 0 indicates no symptoms and a maximum score of 100, represents the most severe symptoms. Higher WOMAC scores correspond to worse outcomes, indicating more significant pain, stiffness, and functional limitations associated with osteoarthritis. The primary outcome for the purpose of this study will be the proportion of patients experiencing a change of at least 30% in WOMAC-pain score after 3 months of intervention compared to the control group.

Secondary Outcome Measures

Full Information

First Posted
October 6, 2023
Last Updated
October 13, 2023
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT06080347
Brief Title
Effect of Anti-inflammatory Diet in Osteoarthritis
Official Title
An Evaluator-blinded Randomized Controlled Trial Study of the Effect of Anti-inflammatory Diet in Subjects With Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (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

5. Study Description

Brief Summary
In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites. The current study will determine whether or not the addition of anti-inflammatory diet improves the clinical outcomes in participants with Osteoarthritis, and the role of microbiome and circulating metabolites.

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
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm_1
Arm Type
Active Comparator
Arm Description
Anti-inflammatory Diet
Arm Title
Arm_2
Arm Type
Experimental
Arm Description
Healthy Diet
Intervention Type
Other
Intervention Name(s)
Anti-inflammatory Diet
Intervention Description
Dietary intervention
Intervention Type
Other
Intervention Name(s)
Healthy Diet
Intervention Description
Dietary intervention
Primary Outcome Measure Information:
Title
Change in Knee Osteoarthritis Pain
Description
The Western Ontario and McMaster Universities Osteoarthritis Index, known as the WOMAC score, is a validated questionnaire used for evaluating pain, stiffness, and physical function in individuals with knee or hip osteoarthritis. A minimum score of 0 indicates no symptoms and a maximum score of 100, represents the most severe symptoms. Higher WOMAC scores correspond to worse outcomes, indicating more significant pain, stiffness, and functional limitations associated with osteoarthritis. The primary outcome for the purpose of this study will be the proportion of patients experiencing a change of at least 30% in WOMAC-pain score after 3 months of intervention compared to the control group.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral radiographic symptomatic KOA No changes in therapy during the previous 3 months Interested in dietary intervention and able to provide consent and attend follow-up visits Exclusion Criteria: Previous knee surgery Severe radiographic disease (KL grade 4) Rheumatoid Arthritis Any Abnormal blood values in the comprehensive metabolic panel test at screen (Abnormality will be defined based on standard reference ranges) Use of corticosteroids and/or intra-articular injections during the preceding 3 months Use of fish oils and glucosamine Participation in a weight loss program in the preceding 6 months Recent changes in physical activity levels Regular smoking Patients with food allergies Patient with other medical conditions that will impair the ability to participate in a nutritional study Plan to change systemic therapy Patients unwilling to change dietary habits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Guma, M.D., PhD
Phone
8588226523
Email
mguma@health.ucsd.edu
Facility Information:
Facility Name
University of California
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Guma, M.D, PHD
Email
mguma@health.ucsd.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Anti-inflammatory Diet in Osteoarthritis

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