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

NCT ID: NCT01073982

Last Updated: 2011-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-01-31

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.

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.

Conditions

Pain; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

cherry flavored fruit drink

Group Type: PLACEBO_COMPARATOR

tart cultivar Montmorency cherry juice

Intervention Type: DIETARY_SUPPLEMENT

21 ounces of experimental or placebo juice, consumed daily for 21 days.

tart cherry juice

Group Type: EXPERIMENTAL

tart cultivar Montmorency cherry juice

Intervention Type: DIETARY_SUPPLEMENT

21 ounces of experimental or placebo juice, consumed daily for 21 days.

Interventions

tart cultivar Montmorency cherry juice

21 ounces of experimental or placebo juice, consumed daily for 21 days.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cherry Research Committee

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Oregon Health and Science University

Principal Investigators

Kerry S Kuehl, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

e5825

Identifier Type: -

Identifier Source: org_study_id