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Efficacy of Tart Cherry Juice to Reduce Pain and Inflammation Among Patients With Inflammatory Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01073982
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : January 20, 2011
Sponsor:
Collaborator:
Cherry Research Committee
Information provided by:
Oregon Health and Science University

Study Description
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Brief Summary:
The purpose of this study is to assess the effects of tart cherry juice to reduce pain and inflammation among individuals with arthritis.

Condition or disease Intervention/treatment Phase
Pain Inflammation Dietary Supplement: tart cultivar Montmorency cherry juice Phase 4

Detailed Description:
Numerous antioxidant and anti-inflammatory agents have been identified in tart cherries, and a study among healthy, non-exercising individuals demonstrated that cherry consumption decreased serum inflammatory biomarkers after 14 days. Osteoarthritis (OA) is a common syndrome affecting 65 million Americans characterized by pain, inflammation, and disability. Such natural anti-inflammatory effects of cherry consumption may be beneficial for the management and treatment of osteoarthritis and inflammatory diseases. The purpose of this randomized, double-blind, placebo controlled study is to examine individuals with inflammatory OA and assess the analgesic and anti-inflammatory effects of tart cherry juice as compared to a placebo drink among twenty 30-70 y/o OA subjects.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Tart Cherry Juice to Reduce Pain and Inflammation Among Patients With Inflammatory Osteoarthritis
Study Start Date : February 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: cherry flavored fruit drink Dietary Supplement: tart cultivar Montmorency cherry juice
21 ounces of experimental or placebo juice, consumed daily for 21 days.
Experimental: tart cherry juice Dietary Supplement: tart cultivar Montmorency cherry juice
21 ounces of experimental or placebo juice, consumed daily for 21 days.


Outcome Measures
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Primary Outcome Measures :
  1. Primary outcomes include measurement of interleukin 10 (IL-10), CRP, and a specific group of cytokines that provide a generalized measurement of inflammatory activity, these include IL-6 and TNF-α. [ Time Frame: 6-8 months ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with inflammatory osteoarthritis
  • In good general health
  • Stable pattern of anti-inflammatory or pain relieving drug use for 3 months prior to study
  • Ability and willingness to maintain consistent pattern of anti-inflammatory or pain relieving drug use during the course of the study, and to not seek any other treatment during the study
  • Ability and willingness to consume juice or placebo drink for 21 consecutive days, and to participate in screening measures, including a blood draw, before and after the intervention period

Exclusion Criteria:

  • Pregnancy
  • Serious medical conditions such as recent heart attack or stroke, cancer, diabetes (type 1 and type 2), or gastrointestinal ulcers
  • Individuals who have not been on a stable dose of pain medications or pain modalities for at least 3 months, including muscle relaxants, tender point anesthetic injections, systemic or intrabursal or intraarticular steroids, or any investigational drug/device in the prior 90 days
  • Individuals who have used nonpharmacologic pain therapies including acupuncture, ultrasound, or transcutaneous electrical nerve stimulation within the past 30 days
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073982


Locations
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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Cherry Research Committee
Investigators
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Principal Investigator: Kerry S Kuehl, MD, PhD Oregon Health and Science University
More Information
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Responsible Party: Kerry S. Kuehl MD PhD/Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01073982    
Other Study ID Numbers: e5825
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: January 20, 2011
Last Verified: January 2011
Keywords provided by Oregon Health and Science University:
pain
inflammation
osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Inflammation
Arthritis
Joint Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes