An interventional study of Plant-based diet and Supplement in Rheumatoid Arthritis, sponsored by Physicians Committee for Responsible Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-06-18.
Sponsored by Physicians Committee for Responsible Medicine · Not applicable, Interventional, and Supportive care
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 2 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Physicians Committee for Responsible Medicine is the lead sponsor of 32 studies on the registry; 4 are open to participants now.
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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):
Exclusion Criteria:
The diet group will be asked to follow a low-fat, vegan diet for 16 weeks
Other: Plant-based diet
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
Weekly instructions will be given to the participants in the intervention group about following vegan diet.
Unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E
Also known as: Vitamin E
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
Time frame: 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.
Time frame: 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.
Time frame: Change in mood from Baseline at 4 months
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.
Time frame: Change in quality of life from Baseline at 4 months
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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