Back to results

Efficacy of Proprietary Cherry Juice Blend in Osteoarthritis of the Knee

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

proprietary cherry juice blend (food)

control juice (kool aid blend)

About this trial

This is an interventional supportive care trial for Osteoarthritis focused on measuring osteoarthritis, gout, pain, uric acid, tart cherry, alternative medicine, knees

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

Improvement in Western Ontario McMaster Osteoarthritis Index (WOMAC) Scores to be taken at Visits 2-5.

Secondary Outcome Measures

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).

Determine if there is a decrease in serum uric acid levels. (Visits 1,3,5)

Full Information

NCT ID

NCT00443092

First Posted

March 2, 2007

Last Updated

August 1, 2012

Sponsor

CherryPharm

1. Study Identification

Unique Protocol Identification Number

NCT00443092

Brief Title

Efficacy of Proprietary Cherry Juice Blend in Osteoarthritis of the Knee

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

CherryPharm

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

osteoarthritis, gout, pain, uric acid, tart cherry, alternative medicine, knees

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

proprietary cherry juice blend (food)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

control juice (kool aid blend)

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement in Western Ontario McMaster Osteoarthritis Index (WOMAC) Scores to be taken at Visits 2-5.

Time Frame

Visit 3 (week 6-7), Visit 5 (week 13-14)

Secondary Outcome Measure Information:

Title

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).

Time Frame

Visit 3 (week 6-7), Visit 5 (week 13-14)

Title

Determine if there is a decrease in serum uric acid levels. (Visits 1,3,5)

Time Frame

Visit 3 (week 6-7), Visit 5 (week 13-14)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

H. R Schumacher, M.D.

Organizational Affiliation

VA Medical Center, Philadelphia & University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Medical Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

14776685

Citation

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

Results Reference

background

PubMed Identifier

16790484

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

Results Reference

background

PubMed Identifier

11695879

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. doi: 10.1078/0944-7113-00053.

Results Reference

background

PubMed Identifier

17062434

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. doi: 10.1080/03009740600704155.

Results Reference

background

PubMed Identifier

12771324

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. doi: 10.1093/jn/133.6.1826.

Results Reference

background

PubMed Identifier

15082468

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

Results Reference

background

PubMed Identifier

15118030

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

Results Reference

background

PubMed Identifier

3741515

Citation

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.

Results Reference

background

Learn more about this trial

Efficacy of Proprietary Cherry Juice Blend in Osteoarthritis of the Knee

We'll reach out to this number within 24 hrs