NCT03580681

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

A Nutrition Intervention for Arthritis-4

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Physicians Committee for Responsible Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
OTHER	Plant-based diet	Weekly instructions will be given to the participants in the intervention group about following vegan diet.
DIETARY_SUPPLEMENT	Supplement	Unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E

Timeline

• Start date: 2018-08-22
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2018-07-09
• Last updated: 2021-06-18

Locations

1 site across 1 country: United States