Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments plant-based diet, supplement
Sponsor Physicians Committee for Responsible Medicine
Start date October 2012
End date October 2013
Trial size 6 participants
Trial identifier NCT01700881, WCCR-ARTH-2

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
The diet group will be asked to follow a low-fat, vegan diet for 16 weeks
plant-based diet Vegan diet
Weekly instructions will be given to the participants in the intervention group about following vegan diet.
(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.
supplement Vitamin E
Unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E

Primary Outcomes

Measure
Pain Score
time frame: Change in pain score from Baseline at 4 months
Disease Activity score
time frame: Change in disease activity score from Baseline at 4 months
Improvement in mood
time frame: Change in mood from Baseline at 4 months
Improvement in depression
time frame: Change in depression from Baseline at 4 months

Secondary Outcomes

Measure
Quality of Life
time frame: Change in quality of life from Baseline at 4 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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: 1. Involvement of 1 large joint gives 0 points 2. Involvement of 2-10 large joints gives 1 point 3. Involvement of 1-3 small joints (with or without involvement of large joints) gives 2 points 4. Involvement of 4-10 small joints (with or without involvement of large joints) gives 3 points 5. 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): 1. Negative RF and negative ACPA gives 0 points 2. Low-positive RF or low-positive ACPA gives 2 points 3. 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 - Rheumatoid arthritis for more than 6 years - 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

Additional Information

Official title A Nutrition Intervention for Arthritis-2
Principal investigator Neal D Barnard, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Physicians Committee for Responsible Medicine.