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NCT01939262 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Essentia Health.

Completed
Registry status
NA
Development phase
40
Enrollment target

NCT01939262 is a NA study that has completed, run by Essentia Health. The registered enrollment target is 40 participants.

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The verdict

NCT01939262, a NA study, has completed, sponsored by Essentia Health.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target

Study 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.

Interventions

  • OTHER Control
  • OTHER Limitation of Animal Fat and Protein in the Diet

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2010-12
Est. Completion 2012-02
Phase NA

Sponsor

Essentia Health

17 total trials

What the Registry Record Tells You About NCT01939262

The ClinicalTrials.gov registry entry for NCT01939262 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Essentia Health, which has 17 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.

NCT01939262 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01939262 about?

NCT01939262 is a clinical study titled "The Impact of Dietary Restriction of Animal Protein and Fat on 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 ...

What is the current status of trial NCT01939262?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2010-12. Estimated completion is 2012-02.

What interventions are being tested in trial NCT01939262?

The interventions under investigation include: Control (OTHER), Limitation of Animal Fat and Protein in the Diet (OTHER).

Who is sponsoring clinical trial NCT01939262?

This trial is sponsored by Essentia Health, which has 17 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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