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

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

Detailed Description
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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.

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

Conditions
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Pain, Inflammation

Intervention / Treatment
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* Dietary Supplement: tart cultivar Montmorency cherry juice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: cherry flavored fruit drink<br> | Dietary Supplement: tart cultivar Montmorency cherry juice<br>* 21 ounces of experimental or placebo juice, consumed daily for 21 days.<br>|
| Experimental: tart cherry juice<br> | Dietary Supplement: tart cultivar Montmorency cherry juice<br>* 21 ounces of experimental or placebo juice, consumed daily for 21 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 6-8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, inflammation, osteoarthritis