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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
Participants assigned to the control group will be instructed to follow their usual diets.
- 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
- c-reactive protein [ Time Frame: 6 weeks ]Clinical laboratory tests of c-reactive protein was drawn at the intake and exit of the study .
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
|United States, Michigan|
|Mary R Clifton, MD (private solo practice office)|
|Traverse City, Michigan, United States, 49684|
|Principal Investigator:||Mary R Clifton, MD||Essentia Health|