Effect of Anti-inflammatory Diet in Osteoarthritis

NCT06080347 | Recruiting

• 1 other identifier: 807845
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (2)

Arm_1

ACTIVE COMPARATOR

Anti-inflammatory Diet

Other: Anti-inflammatory Diet

Arm_2

EXPERIMENTAL

Healthy Diet

Other: Healthy Diet

Interventions

Anti-inflammatory Diet OTHER

Dietary intervention

Arm_1

Healthy Diet OTHER

Dietary intervention

Arm_2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California

San Diego, California, 92122, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Monica Guma, M.D., PhD

CONTACT

8588226523; mguma@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: October 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)