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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
| 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 |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
No publications provided
| 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 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Oregon Health and Science University:
|
pain inflammation osteoarthritis |
Additional relevant MeSH terms:
|
Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on March 03, 2015