The Impact of Dietary Restriction of Animal Protein and Fat on Osteoarthritis

The Impact of Dietary Restriction of Animal Protein and Fat on Subjective Complaints of Osteoarthritis

Patients will be randomized into the control or intervention group. Based on patient preference, the intervention group will be trained for one hour in either individual or group format on vegan diet. They will also be directed to www.pcrm.org and www.drmarymd.com for low glycemic, animal free, low fat food options and support. The control group will continue their normal omnivorous diet program. Twenty-four hour food recalls will be obtained at the start and end of the trial, and once a week for the 6 weeks of the trial by telephone. Patients will undergo a final interview at the end of the 6 week study period. The intervention group should strive to obtain 90% of their calories from plants. They will be encouraged to eat freely and not count calories. Patients will undergo additional individual consultation as needed to promote compliance and answer specific questions.

Over the 6 weeks, the Patient Global Improvement of Change (PGIC) and the 36 item short form health survey (SF-36) will be performed weekly by telephone. Patient will perform a Visual Analog Scale (VAS) of their pain level randomly daily on their own. C-reactive protein levels will be assessed at the beginning and end of the study at Munson Medical Center Laboratories as a secondary measure of diet changes.

There have been no published prospective randomized controlled trials assessing whether a vegan diet would benefit osteoarthritis. The specific aim of this study is to determine if a vegan diet will result in subjective reduction in perceived pain and limitations to function in patients with osteoarthritis.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Other: Limitation of Animal Fat and Protein in the Diet; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Traverse City, Michigan, United States, 49684
      • Mary R Clifton, MD (private solo practice office)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Community dwelling
• Medical Provider diagnosis of Osteoarthritis

Exclusion Criteria:

• Pre-existing vegans or vegetarians
• Ages less than 18 or greater than 70
• History of an eating disorder
• History of diabetes
• Inability to afford food
• Lack of control over the food eaten
• Pregnant or nursing
• Known food allergies
• Patients following a medically prescribed diet

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vegan Diet; Limitation of Animal Fat and Protein in the Diet. Animal products were proscribed and the use of unrefined foods was encouraged. Participants were asked to limit high-fat plant foods, such as nuts, avocados, and refined oils. There was no restriction in energy intake, were encouraged to eat freely and not count calories.	Other: Limitation of Animal Fat and Protein in the Diet; Animal products were proscribed and the use of unrefined foods was encouraged. Participants were asked to limit high-fat plant foods, such as nuts, avocados, and refined oils. There was no restriction in energy intake, were encouraged to eat freely and not count calories.
Placebo Comparator: Control; Subjects maintained their existing diet without modification.	Other: Control; Participants assigned to the control group will be instructed to follow their usual diets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Complaints of Pain and Functionality in Osteoarthritis Patients	Significant responders were defined as patients that experienced a clinically significant improvement in at least two of the three administered tests: pain, as measured by a 30% improvement on the VAS(Visual Analog Scale) and improvement in patient's global status, measured by a rating of somewhat better to a great deal better on the PGIC scale, and physical function, a >6 point improvement on the 36-item short form health survey (SF-36v2) Role Physical or Physical Component Summary Score	Six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
c-reactive protein	Clinical laboratory tests of c-reactive protein was drawn at the intake and exit of the study .	6 weeks

Collaborators and Investigators

• Sponsor: Essentia Health
• Collaborators: Blue Cross Blue Shield of Michigan Foundation
• Investigators: Principal Investigator: Mary R Clifton, MD, Essentia Health

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: September 5, 2013
• First Submitted That Met QC Criteria: September 5, 2013
• First Posted (Estimate): September 11, 2013

Study Record Updates

• Last Update Posted (Estimate): September 20, 2013
• Last Update Submitted That Met QC Criteria: September 19, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Arthritis; Pain; Diet; Function; Vegan; Restriction; Vegetarian
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: Osteoarthritis Diet