OsteoarthritisNCT01939262
The Impact of Dietary Restriction of Animal Protein and Fat on Osteoarthritis
A study testing Limitation of Animal Fat and Protein in the Diet in people with Osteoarthritis, run by Essentia Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Limitation of Animal Fat and Protein in the Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community dwelling
- Medical Provider diagnosis of Osteoarthritis
Who cannot join
- 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
Show all 9Show fewer
- Pregnant or nursing
- Known food allergies
- Patients following a medically prescribed diet
Trial locations and contacts
1 site in 1 country.
United States1 site
Mary R Clifton, MD (private solo practice office)
Traverse City, Michigan, 49684
About this study
Official title: The Impact of Dietary Restriction of Animal Protein and Fat on Subjective Complaints of Osteoarthritis
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
- Being tested
- Limitation of Animal Fat and Protein in the Diet, Control
- Keywords
- Arthritis, Pain, Function, Diet, Vegan, Vegetarian, Restriction
- Medical subject headings
- Osteoarthritis, Arthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limitation of Animal Fat and Protein in the DietOther
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.
ControlOther
Participants assigned to the control group will be instructed to follow their usual diets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Limitation of Animal Fat and Protein in the Diet |
| Control | Placebo comparator | Subjects maintained their existing diet without modification. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Six weeks
Secondary outcomes (1)
c-reactive protein
Clinical laboratory tests of c-reactive protein was drawn at the intake and exit of the study .
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startDec 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essentia Health
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Principal investigator, Mary Clifton, Essentia Health
- Investigators
- Mary R Clifton, MD, Principal investigator, Essentia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939262
- Sponsor's protocol ID
- Osteoarthritis Diet
- Status last verified
- Sep 2013
- First submitted
- 5 Sep 2013
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dietary Restriction of Animal Protein and Fat on Subjective Complaints of Osteoarthritis
- ClinicalTrials.gov ID
- NCT01939262
- Acronym / sponsor ID
- Osteoarthritis Diet
- Conditions
- Osteoarthritis
- Keywords
- Arthritis, Pain, Function, Diet, Vegan, Vegetarian, Restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Essentia HealthUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Study start
- Dec 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegan Diet | Experimental | Other: Limitation of Animal Fat and Protein in the DietLimitation 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. |
| Control | Placebo comparator | Other: ControlSubjects maintained their existing diet without modification. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Community dwelling
- Medical Provider diagnosis of Osteoarthritis
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limitation of Animal Fat and Protein in the DietAnimal 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 | Vegan Diet |
| ControlParticipants assigned to the control group will be instructed to follow their usual diets. | Other | Control |
Primary outcome
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
1 secondary outcome
c-reactive protein
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary R Clifton, MD principal investigator
Essentia Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limitation of Animal Fat and Protein in the Diet in people with Osteoarthritis, run by Essentia Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Complaints of Pain and Functionality in Osteoarthritis Patients (time frame: Six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.