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

Essentia Health

Status: Completed

Conditions: Osteoarthritis

Treatments: Other: Limitation of Animal Fat and Protein in the Diet; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT01939262

Osteoarthritis Diet

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Vegan Diet

Experimental group

Description:

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.

Treatment:

Other: Limitation of Animal Fat and Protein in the Diet

Control

Placebo Comparator group

Description:

Subjects maintained their existing diet without modification.

Treatment:

Other: Control