A Nutrition Intervention for Arthritis -2 (WCCR-ARTH2)
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Nutrition Intervention for Arthritis-2|
- Pain Score [ Time Frame: Change in pain score from Baseline at 4 months ] [ Designated as safety issue: No ]will be measured by visual analog scale
- Disease Activity score [ Time Frame: Change in disease activity score from Baseline at 4 months ] [ Designated as safety issue: No ]measured by number of painful, swollen and tender joints
- Improvement in mood [ Time Frame: Change in mood from Baseline at 4 months ] [ Designated as safety issue: No ]measured by the Beck Depression Inventory II (BDI-II).
- Improvement in depression [ Time Frame: Change in depression from Baseline at 4 months ] [ Designated as safety issue: No ]measured by Epidemiologic Studies Depression Scale-Revised (CESD-R).
- Quality of Life [ Time Frame: Change in quality of life from Baseline at 4 months ] [ Designated as safety issue: No ]measured by a modified health assessment questionnaire
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||June 2016|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Plant-based diet
The diet group will be asked to follow a low-fat, vegan diet for 16 weeks
Other: Plant-based diet
Weekly instructions will be given to the participants in the intervention group about following vegan diet.
Other Name: Vegan diet
Placebo Comparator: Supplement
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.
Unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E
Other Name: Vitamin E
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700881
|United States, District of Columbia|
|Physicians Committee for Responsible Medicine|
|Washington, District of Columbia, United States, 20016|
|Principal Investigator:||Neal D Barnard, MD||Physicians Committee for Responsible Medicine|