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

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ClinicalTrials.gov Identifier: NCT01939262
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : September 20, 2013
Sponsor:
Collaborator:
Blue Cross Blue Shield of Michigan Foundation
Information provided by (Responsible Party):
Mary Clifton, Essentia Health

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis Other: Limitation of Animal Fat and Protein in the Diet Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Dietary Restriction of Animal Protein and Fat on Subjective Complaints of Osteoarthritis
Study Start Date : December 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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.




Primary Outcome Measures :
  1. Subjective Complaints of Pain and Functionality in Osteoarthritis Patients [ Time Frame: Six weeks ]
    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


Secondary Outcome Measures :
  1. c-reactive protein [ Time Frame: 6 weeks ]
    Clinical laboratory tests of c-reactive protein was drawn at the intake and exit of the study .



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT01939262


Locations
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United States, Michigan
Mary R Clifton, MD (private solo practice office)
Traverse City, Michigan, United States, 49684
Sponsors and Collaborators
Essentia Health
Blue Cross Blue Shield of Michigan Foundation
Investigators
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Principal Investigator: Mary R Clifton, MD Essentia Health

Additional Information:
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Responsible Party: Mary Clifton, Medical Doctor, Essentia Health
ClinicalTrials.gov Identifier: NCT01939262     History of Changes
Other Study ID Numbers: Osteoarthritis Diet
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: September 2013

Keywords provided by Mary Clifton, Essentia Health:
Arthritis
Pain
Function
Diet
Vegan
Vegetarian
Restriction

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases