A Nutrition Intervention for Arthritis -4 (WCCR-ARTH4)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Nutrition Intervention for Arthritis-4

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: Plant-based diet
* Dietary Supplement: Supplement


Participation Criteria
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Eligibility Criteria
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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: Involvement of 1 large joint gives 0 points Involvement of 2-10 large joints gives 1 point Involvement of 1-3 small joints (with or without involvement of large joints) gives 2 points Involvement of 4-10 small joints (with or without involvement of large joints) gives 3 points Involvement of more than 10 joints (with involvement of at least 1 small joint) gives 5 points Serological parameters - including the rheumatoid factor as well as anti-citrullinated protein antibody (ACPA): Negative RF and negative ACPA gives 0 points Low-positive RF or low-positive ACPA gives 2 points High-positive RF or high-positive ACPA gives 3 points Acute phase reactants: 1 point for elevated erythrocyte sedimentation rate (ESR) or elevated C-reactive protein (CRP) value Duration of arthritis: 1 point for symptoms lasting six weeks or longer 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: < 18 years of age Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion) Pregnancy Unstable medical or psychiatric illness Likely to be disruptive in group sessions (as determined by research staff) Already following a low-fat, vegan diet Lack of English fluency Inability to maintain current medication regimen Inability or unwillingness to participate in all components of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plant-based diet<br>The diet group will be asked to follow a low-fat, vegan diet for 16 weeks | Other: Plant-based diet<br>* Weekly instructions will be given to the participants in the intervention group about following vegan diet.<br>|
| Placebo Comparator: Supplement<br>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. | Dietary Supplement: Supplement<br>* Unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E<br>* Other names: Vitamin E;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 from scores below 2.6, indicating disease remission, to more than 5.1, indicating severe disease activity. | Change in disease activity score from Baseline at 4 months | 
| Improvement in mood | measured by the Beck Depression Inventory II (BDI-II), with scores ranging from 0 indicating minimal depression to 63, indicating severe depression. | Change in mood from Baseline at 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life of Mood | 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 in order to determine overall quality of life. | Change in quality of life from Baseline at 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Diet, Fat-Restricted, Vegeterian