NCT06080347 · University of California, San Diego
Effect of Anti-inflammatory Diet in Osteoarthritis
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Anti-inflammatory Diet
Dietary intervention
OTHER
Healthy Diet
Dietary intervention
Primary outcome measures
Change in Knee Osteoarthritis Pain
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- San Diego, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 4, 2024 · Source of record for eligibility and locations