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Efficacy of Tart Cherry Juice to Reduce Pain and Inflammation Among Patients With Inflammatory Osteoarthritis
This study has been completed.
Sponsor:
Oregon Health and Science University
Collaborator:
Cherry Research Committee
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01073982
First received: February 12, 2010
Last updated: January 19, 2011
Last verified: January 2011
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Purpose
The purpose of this study is to assess the effects of tart cherry juice to reduce pain and inflammation among individuals with arthritis.
| Condition | Intervention | Phase |
|---|---|---|
| Pain Inflammation | Dietary Supplement: tart cultivar Montmorency cherry juice | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy of Tart Cherry Juice to Reduce Pain and Inflammation Among Patients With Inflammatory Osteoarthritis |
Resource links provided by NLM:
Further study details as provided by Oregon Health and Science University:
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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.
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years (Adult, Senior) |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01073982
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073982
Locations
| 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
| Principal Investigator: | Kerry S Kuehl, MD, PhD | Oregon Health and Science University |
More Information
| Responsible Party: | Kerry S. Kuehl MD PhD/Associate Professor, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT01073982 History of Changes |
| Other Study ID Numbers: |
e5825 |
| Study First Received: | February 12, 2010 |
| Last Updated: | January 19, 2011 |
Keywords provided by Oregon Health and Science University:
|
pain inflammation osteoarthritis |
Additional relevant MeSH terms:
|
Osteoarthritis Inflammation Arthritis Joint Diseases |
Musculoskeletal Diseases Rheumatic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on July 21, 2017