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临床试验/NCT01939262
NCT01939262已完成不适用

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

Essentia Health2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Subjective Complaints of Pain and Functionality in Osteoarthritis Patients

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Community dwelling
  • Medical Provider diagnosis of Osteoarthritis

排除标准

  • 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

结局指标

主要结局

Subjective Complaints of Pain and Functionality in Osteoarthritis Patients

时间窗: 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

次要结局

  • c-reactive protein(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Clifton

Medical Doctor

Essentia Health

研究点 (2)

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