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

NCT03580681 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-06-18

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Physicians Committee for Responsible Medicine

    lead OTHER

Principal Investigators

  • Neal D Barnard · Physicians Committee for Responsible Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-22
Primary Completion
2020-06-01
Completion
2020-06-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03580681 on ClinicalTrials.gov