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The purpose of the study is to assess whether, in individuals with rheumatoid arthritis, a low-fat, vegan diet improves pain and other subjective symptoms more effectively than a control supplement or a placebo. The principal measure is pain as measured by Visual Analog Scale (VAS) and disease activity as measured by number of painful swollen and tender joints, respectively. The study duration is 36 weeks.
Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional supplements can help reduce pain and also reduce the need for pain medications for some people. The investigators will ask about 100 people to participate. All of them will get a low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a placebo), although some will get the diet first, and others will get the supplement first. This order in which they will get the diet and the supplement will be determined randomly, that is, by chance (like the toss of a coin). The principal measure is pain as measured by Visual Analog Scale (VAS) and disease activity as measured by number of painful swollen and tender joints, respectively. The study duration is 36 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vegan Diet | Experimental |
| |
| Supplement | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vegan Diet | Other | Vegan diet, which is devoid of animal products and minimal in fat |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | will be measured by visual analog scale | Baseline and 4 months |
| Disease Activity score | measured by number of painful, swollen and tender joints | Baseline and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | measured by a modified health assessment questionnaire | Baseline and 4 months |
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Inclusion Criteria:
A diagnosis of rheumatoid arthritis, as defined below.
A diagnosis of rheumatoid arthritis is based on 2010 ACR / EULAR Rheumatoid Arthritis Classification Criteria. Classification as "definite RA" is based on the confirmed presence of synovitis in at least 1 joint, absence of an alternative diagnosis that better explains the synovitis, and achievement of a total score of 6 or greater (of a possible 10): 24
Joint involvement, designating the metacarpophalangeal joints, proximal interphalangeal joints, the interphalangeal joint of the thumb, second through third metatarsophalangeal joint and wrist as small joints, and elbows, hip joints and knees as large joints:
Serological parameters - including the rheumatoid factor as well as anti-citrullinated protein antibody (ACPA):
Continuing or recurring pain (i.e., joint pain daily, unless on pain medication).
Age at least 18 years
Ability and willingness to participate in all components of the study
Willingness to be assigned to either the diet group or supplement group
Pain medications unchanged within last 6 weeks.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neal Barnard, MD | Physicians Committee for Responsible Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Committee for Responsible Medicine | Washington D.C. | District of Columbia | 20016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39981557 | Derived | Barnard ND, Levin S, Crosby L, Flores R, Holubkov R, Kahleova H. A Randomized, Crossover Trial of a Nutritional Intervention for Rheumatoid Arthritis. Am J Lifestyle Med. 2022 Apr 3;19(2):266-275. doi: 10.1177/15598276221081819. eCollection 2025 Feb. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000067269 | Diet, Vegan |
| ID | Term |
|---|---|
| D014676 | Diet, Vegetarian |
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
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| dietary supplement omega3 fatty acids aand vitamins |
| Dietary Supplement |
mixture of omega3 fatty acids aand vitamins |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |