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

NCT01939262 | Completed

• 1 other identifier: Osteoarthritis Diet
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Subjective Complaints of Pain and Functionality in Osteoarthritis Patients

  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

  Six weeks

Secondary Outcomes (1)

• c-reactive protein

  6 weeks

Study Arms (2)

Vegan Diet

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

Subjects maintained their existing diet without modification.

Other: Control

Interventions

Limitation of Animal Fat and Protein in the Diet 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.

Vegan Diet

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community dwelling
• Medical Provider diagnosis of Osteoarthritis

You may not qualify if:

• 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

Sponsors & Collaborators

• Essentia Health: lead
• Blue Cross Blue Shield of Michigan Foundation: collaborator

Study Sites (1)

Mary R Clifton, MD (private solo practice office)

Traverse City, Michigan, 49684, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis; Pain

Interventions

Proteins

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Mary R Clifton, MD

  Essentia Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 11, 2013
• Study Start: December 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: September 20, 2013

Record last verified: 2013-09

Locations

US (1)