Effect of Anti-inflammatory Diet in Osteoarthritis

Sponsor

University of California, San Diego (Other)

Overall Status

Recruiting

CT.gov ID

NCT06080347

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Other: Anti-inflammatory Diet Other: Healthy Diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

An Evaluator-blinded Randomized Controlled Trial Study of the Effect of Anti-inflammatory Diet in Subjects With Osteoarthritis

Actual Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm_1 Anti-inflammatory Diet	Other: Anti-inflammatory Diet Dietary intervention
Experimental: Arm_2 Healthy Diet	Other: Healthy Diet Dietary intervention

Arm

Intervention/Treatment

Active Comparator: Arm_1

Anti-inflammatory Diet

Other: Anti-inflammatory Diet

Dietary intervention

Experimental: Arm_2

Healthy Diet

Other: Healthy Diet

Dietary intervention

Outcome Measures

Primary Outcome Measures

Change in Knee Osteoarthritis Pain [3 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California	San Diego	California	United States	92122

Sponsors and Collaborators

University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Monica Guma, Associate Professor, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT06080347

Other Study ID Numbers:

807845

First Posted:

Oct 12, 2023

Last Update Posted:

Oct 17, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Anti-Inflammatory Agents

Study Results

No Results Posted as of Oct 17, 2023