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

NCT ID: NCT01939262

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-02-29

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.

Conditions

Osteoarthritis

Keywords

Arthritis; Pain; Function; Diet; Vegan; Vegetarian; Restriction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Limitation of Animal Fat and Protein in the Diet

Intervention Type: OTHER

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.

Control

Subjects maintained their existing diet without modification.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

Participants assigned to the control group will be instructed to follow their usual diets.

Interventions

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.

Intervention Type: OTHER

Control

Participants assigned to the control group will be instructed to follow their usual diets.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Blue Cross Blue Shield of Michigan Foundation

OTHER

Sponsor Role: collaborator

Essentia Health

OTHER

Sponsor Role: lead

Responsible Party

Mary Clifton

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary R Clifton, MD

Role: PRINCIPAL_INVESTIGATOR

Essentia Health

Locations

Mary R Clifton, MD (private solo practice office)

Traverse City, Michigan, United States

Countries

United States

Other Identifiers

Osteoarthritis Diet

Identifier Type: -

Identifier Source: org_study_id