Effect of Anti-inflammatory Diet in Osteoarthritis

NCT ID: NCT06080347

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Arm_1

Anti-inflammatory Diet

Group Type ACTIVE_COMPARATOR

Anti-inflammatory Diet

Intervention Type OTHER

Dietary intervention

Arm_2

Healthy Diet

Group Type EXPERIMENTAL

Healthy Diet

Intervention Type OTHER

Dietary intervention

Interventions

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Anti-inflammatory Diet

Dietary intervention

Intervention Type OTHER

Healthy Diet

Dietary intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Monica Guma

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Monica Guma, M.D., PhD

Role: CONTACT

8588226523

Facility Contacts

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Monica Guma, M.D, PHD

Role: primary

Other Identifiers

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807845

Identifier Type: -

Identifier Source: org_study_id

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