A Nutrition Intervention for Arthritis -3 (WCCR-ARTH3)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03417648|
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : April 10, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Other: Plant-based diet Other: Supplement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Nutrition Intervention for Arthritis-3|
|Actual Study Start Date :||March 8, 2018|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
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.
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
- Pain Score [ Time Frame: Change in pain score from Baseline at 4 months ]will be measured by visual analog scale from 0%, indicating no pain, to 100%, indicating pain as bad as it could possibly be
- Disease Activity score [ Time Frame: Change in disease activity score from Baseline at 4 months ]measured by number of painful, swollen and tender joints
- Improvement in mood [ Time Frame: Change in mood from Baseline at 4 months ]measured by the Beck Depression Inventory II (BDI-II).
- Quality of Life [ Time Frame: Change in quality of life from Baseline at 4 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417648
|Contact: Jihad Alwarithemail@example.com|
|United States, District of Columbia|
|Physicians Committee for Responsible Medicine||Recruiting|
|Washington, District of Columbia, United States, 20016|
|Contact: Jihad Alwarith 202-527-7363 firstname.lastname@example.org|
|Principal Investigator: Neal Barnard|
|Principal Investigator:||Neal D Barnard||Physicians Committee for Responsible Medicine|