Clinical trial NCT01939262: The Impact of Dietary Restriction of Animal Protein and Fat on Osteoarthritis
Official title: The Impact of Dietary Restriction of Animal Protein and Fat on Subjective Complaints of Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Arthritis
Pain
Function
Diet
Vegan
Vegetarian
Restriction
Lead sponsor: Essentia Health
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
First posted: 2013-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Subjective Complaints of Pain and Functionality in Osteoarthritis Patients
timeFrame: Six weeks
Secondary outcomes:
measure: c-reactive protein
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Traverse City
country: United States
facility: Mary R Clifton, MD (private solo practice office)
state: Michigan
Study officials:
affiliation: Essentia Health
name: Mary R Clifton, MD
role: PRINCIPAL_INVESTIGATOR
References: