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

NCT01073982 | Completed Phase 4

• 1 other identifier: e5825
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Inflammation

Keywords

pain; inflammation; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

cherry flavored fruit drink

PLACEBO COMPARATOR

Dietary Supplement: tart cultivar Montmorency cherry juice

tart cherry juice

EXPERIMENTAL

Dietary Supplement: tart cultivar Montmorency cherry juice

Interventions

tart cultivar Montmorency cherry juice DIETARY_SUPPLEMENT

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

cherry flavored fruit drink; tart cherry juice

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Cherry Research Committee: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Pain; Inflammation; Osteoarthritis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kerry S Kuehl, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 12, 2010
• First Posted: February 24, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 20, 2011

Record last verified: 2011-01

Locations

US (1)