NCT00443092

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 3, 2012

Status Verified

August 1, 2012

Enrollment Period

3.3 years

First QC Date

March 2, 2007

Last Update Submit

August 1, 2012

Conditions

Osteoarthritis

Keywords

osteoarthritisgoutpainuric acidtart cherryalternative medicineknees

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • 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)

  • 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)

Study Arms (2)

1

EXPERIMENTAL

proprietary tart cherry juice blend (8 oz., BID)

Other: proprietary cherry juice blend (food)

2

PLACEBO COMPARATOR

control juice (color matched kool aid blend),(8 oz., BID)

Other: control juice (kool aid blend)

Interventions

proprietary cherry juice blend (food)OTHER

2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening

1
control juice (kool aid blend)OTHER

2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening

2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Meets clinical ACR criteria
  • Kellgren score of 2-3 on a Standing Knee x-ray within previous 24 months
  • VAS pain score of 4-9 at screening visit

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (8)

  • BLAU LW. Cherry diet control for gout and arthritis. Tex Rep Biol Med. 1950;8(3):309-11. No abstract available.

    PMID: 14776685BACKGROUND

  • 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. doi: 10.1136/bjsm.2005.025429. Epub 2006 Jun 21.

    PMID: 16790484BACKGROUND

  • 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. doi: 10.1078/0944-7113-00053.

    PMID: 11695879BACKGROUND

  • 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. doi: 10.1080/03009740600704155.

    PMID: 17062434BACKGROUND

  • 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. doi: 10.1093/jn/133.6.1826.

    PMID: 12771324BACKGROUND

  • 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. doi: 10.1136/ard.2003.020313. Epub 2004 Apr 13.

    PMID: 15082468BACKGROUND

  • 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(5):902-9. doi: 10.2106/00004623-200405000-00003.

    PMID: 15118030BACKGROUND

  • 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. doi: 10.1002/art.1780290816.

    PMID: 3741515BACKGROUND

MeSH Terms

Conditions

OsteoarthritisGoutPain

Interventions

Food

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesCrystal ArthropathiesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • H. R Schumacher, M.D.

    VA Medical Center, Philadelphia & University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 2, 2007

First Posted

March 5, 2007

Study Start

March 1, 2007

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

August 3, 2012

Record last verified: 2012-08

Locations

US(1)