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

This study has been completed.
Sponsor:
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
  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
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
Osteoarthritis
Pathologic Processes
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014