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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm_1 | Active Comparator | Anti-inflammatory Diet |
|
| Arm_2 | Experimental | Healthy Diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-inflammatory Diet | Other | Dietary intervention |
| |
| Healthy Diet |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monica Guma, M.D., PhD | Contact | 8588226523 | mguma@health.ucsd.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Recruiting | San Diego | California | 92122 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000072001 | Diet, Healthy |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Other |
Dietary intervention |
|
| D012216 |
| Rheumatic Diseases |