Efficacy of Proprietary Cherry Juice Blend in Osteoarthritis of the Knee

Osteoarthritis Clinical Trial

Official title:

A Double Blind Cross-over Study of the Efficacy of a Proprietary Cherry Juice Blend in Osteoarthritis of the Knee.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443092
• Other study ID #: CP100M
• Secondary ID: VA MIRB ID # 009
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2007
• Last updated: August 1, 2012
• Start date: March 2007
• Est. completion date: December 2010

Study information

• Verified date: August 2012
• Source: CherryPharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this research study is to test the ability of a proprietary cherry juice blend to be helpful in the treatment of osteoarthritis (OA) of the knee.

Description:

The primary objective is to determine if the proprietary tart cherry juice blend improves the pain and function in persons with knee osteoarthritis. A secondary objective is to ascertain if the blend lowers serum uric acid.

This is a prospective double blind, placebo controlled cross-over study.

The study will be performed in the Philadelphia VA Medical Center 1 South Rheumatology Clinic with patients meeting ACR criteria for Kellgren grade 2-3 knee osteoarthritis and 4-9 pain severity on a VAS. Fifty patients will be studied with each having 5 visits. Subjects will take either the proprietary cherry blend or placebo for 6 weeks and then switch. WOMAC pain and function will be the primary outcome with acetaminophen use, walking time and serum uric acid as secondary outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Subject is capable of giving informed consent.

• Subject is over 18 years and less than 80 years

• Subject has mild to moderate osteoarthritis of the knee based on all of the following 3:

1. Meets clinical ACR criteria

2. Kellgren score of 2-3 on a Standing Knee x-ray within previous 24 months

3. VAS pain score of 4-9 at screening visit

Exclusion Criteria:

• Rheumatoid arthritis or other systemic inflammatory condition

• Chronic pain syndrome (fibromyalgia)

• Corticosteroid medication in last 2 months, either intra-articular or oral

• Intra-articular injections of hyaluronic acid in last 9 months

• Pregnant women (weight gain might confound degree of knee pain)

• Diabetes

• Inability to discontinue prescription medication for arthritis

• Unstable medical conditions that would likely prevent the subject from completing the study

• Food allergies - cherries, apples

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• proprietary cherry juice blend (food)
2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening
• control juice (kool aid blend)
2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening

Locations

Country	Name	City	State
United States	VA Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
CherryPharm

Country where clinical trial is conducted

United States, 

References & Publications (8)

Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. — View Citation

BLAU LW. Cherry diet control for gout and arthritis. Tex Rep Biol Med. 1950;8(3):309-11. — View Citation

Connolly DA, McHugh MP, Padilla-Zakour OI, Carlson L, Sayers SP. Efficacy of a tart cherry juice blend in preventing the symptoms of muscle damage. Br J Sports Med. 2006 Aug;40(8):679-83; discussion 683. Epub 2006 Jun 21. — View Citation

He YH, Zhou J, Wang YS, Xiao C, Tong Y, Tang JC, Chan AS, Lu AP. Anti-inflammatory and anti-oxidative effects of cherries on Freund's adjuvant-induced arthritis in rats. Scand J Rheumatol. 2006 Sep-Oct;35(5):356-8. — View Citation

Jacob RA, Spinozzi GM, Simon VA, Kelley DS, Prior RL, Hess-Pierce B, Kader AA. Consumption of cherries lowers plasma urate in healthy women. J Nutr. 2003 Jun;133(6):1826-9. — View Citation

Johanson NA, Liang MH, Daltroy L, Rudicel S, Richmond J. American Academy of Orthopaedic Surgeons lower limb outcomes assessment instruments. Reliability, validity, and sensitivity to change. J Bone Joint Surg Am. 2004 May;86-A(5):902-9. — View Citation

Pincus T, Koch G, Lei H, Mangal B, Sokka T, Moskowitz R, Wolfe F, Gibofsky A, Simon L, Zlotnick S, Fort JG. Patient Preference for Placebo, Acetaminophen (paracetamol) or Celecoxib Efficacy Studies (PACES): two randomised, double blind, placebo controlled, crossover clinical trials in patients with knee or hip osteoarthritis. Ann Rheum Dis. 2004 Aug;63(8):931-9. Epub 2004 Apr 13. — View Citation

Seeram NP, Momin RA, Nair MG, Bourquin LD. Cyclooxygenase inhibitory and antioxidant cyanidin glycosides in cherries and berries. Phytomedicine. 2001 Sep;8(5):362-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Western Ontario McMaster Osteoarthritis Index (WOMAC) Scores to be taken at Visits 2-5.		Visit 3 (week 6-7), Visit 5 (week 13-14)	No
Secondary	Determine if there is a decrease in amount of non-prescription pain medication taken and/or improvement in score on a timed walking test (Visits 2,3,4,5).		Visit 3 (week 6-7), Visit 5 (week 13-14)	No
Secondary	Determine if there is a decrease in serum uric acid levels. (Visits 1,3,5)		Visit 3 (week 6-7), Visit 5 (week 13-14)	No