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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.
This study tests that a low fat, plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).
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 Beck Depression Inventory II (BDI-II)will be used to measure changes in mood. The study duration is 36 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant-based diet | Experimental | The diet group will be asked to follow a low-fat, vegan diet for 16 weeks |
|
| Supplement | Placebo Comparator | The supplement group will follow an unrestricted diet, but will be given a pill containing a small, clinically insignificant amount of omega- 3 oils and vitamin E, which will serve as a placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant-based diet | Other | Weekly instructions will be given to the participants in the intervention group about following vegan diet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | will be measured by visual analog scale from 0%, indicating no pain, to 100%, indicating pain as bad as it could possibly be | Change in pain score from Baseline at 4 months |
| Disease Activity score | measured by number of painful, swollen and tender joints | Change in disease activity score from Baseline at 4 months |
| Improvement in mood | measured by the Beck Depression Inventory II (BDI-II). | Change in mood from Baseline at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | measured by a Modified Health Assessment Questionnaire (MHAQ). The questionnaire measures the difficulty level of performing 8 different activities. A score of 0 = the activity can be performed without difficulty. A score of 3 = the activity cannot be performed. The MHAQ is calculated as the average of these scores. | Change in quality of life from Baseline at 4 months |
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Inclusion Criteria:
A diagnosis of rheumatoid arthritis 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 D Barnard | 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 |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D019587 | Dietary Supplements |
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Supplement | Other | unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E |
|
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D005502 | Food |
| D019602 | Food and Beverages |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |