Efficacy of Spearmint Tea in Relieving Osteoarthritis of the Knee

• ClinicalTrials.gov Identifier: NCT01380015
• Recruitment Status: Completed
• First Posted: June 27, 2011
• Last Update Posted: January 23, 2013
• Sponsor: University of Guelph
• Collaborator: Ontario Ministry of Agriculture, Food and Rural Affairs
• Information provided by (Responsible Party): Amanda Wright, Ph.D., University of Guelph

Tracking Information

• First Submitted Date: June 21, 2011
• First Posted Date: June 27, 2011
• Last Update Posted Date: January 23, 2013
• Study Start Date: July 2011
• Actual Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 23, 2011)

• Self-reported ratings of pain and physical function [ Time Frame: Four months ]
  Data collection of self-reported ratings of pain and physical function (WOMAC), self-reported ratings of overall physical and mental health (SF-36), and self-reported changes in the use of concomitant pain and inflammation medications (study diary) will occur at baseline (week 0), mid-treatment (week 8), post-treatment (week 16), and follow-up (week 20).
• Use of concomitant pain/inflammatory medications for the management of osteoarthritis symptoms [ Time Frame: Four months ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 23, 2011)

• Performance-based measures of physical function [ Time Frame: Four months ]
  Data for performance-based assessment of physical function (6-minute walk, stair climb task) will be collected at baseline (week 0), mid-treatment (week 8), post-treatment (week 16), and follow-up (week 20).
• Change in synovial fluid biomarkers of cartilage degradation [ Time Frame: Four months ]
  In a sub-set of participants, a synovial fluid sample will be drawn (i.e. arthocentesis) for the analyses of cartilage degradation biomarkers (GAG, COMP, PGE2, NO) at baseline (week 0) and post-treatment (week 16).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of Spearmint Tea in Relieving Osteoarthritis of the Knee
• Official Title: Human Clinical Trial to Investigate the Effects of High Rosmarinic Acid Spearmint Tea on Markers of Pain, Physical Function and Disease Activity in Osteoarthritis of the Knee

Brief Summary

The purpose of this study is to investigate the benefits of daily consumption of a high rosmarinic acid spearmint tea, developed by the University of Guelph, on measures of pain, physical function and disease activity in osteoarthritis of the knee.

The investigators hypothesize that a spearmint tea high in rosmarinic acid is efficacious in mitigating the symptoms of osteoarthritis of the knee through its actions in reducing cartilage degradation, oxidative stress and inflammation.

Detailed Description

Healthy adults with a clinical diagnosis of osteoarthritis of the knee will be recruited and will undergo a brief phone screening interview, followed by a detailed in-person screening process, to determine study eligibility.

Eligible participants will be matched according to sex, baseline pain according to the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score, and duration of osteoarthritis. Participants will then be randomly assigned to receive either the investigative high rosmarinic acid spearmint tea or a comparable placebo mint tea.

During the 4-month treatment period, participants will consume two cups (300 mL in the morning and 300 mL in the evening) of either the high rosmarinic acid spearmint tea (approximately 300 mg rosmarinic acid per day) or the commercial spearmint tea (approximately 20 mg of rosmarinic acid per day) daily.

Data collection will occur at baseline (week 0), mid-treatment (week 8), post-treatment (week 16), and follow-up (week 20). Outcome measures include WOMAC and SF-36 scores, physical function (6-minute walk, stair climb task), inflammatory markers (serum C-reactive protein), and self-reported changes in pain medication use. In a sub-set of consenting participants deemed eligible by the study physician, a synovial fluid sample will be drawn from the knee for the analyses of cartilage degradation biomarkers (GAG, COMP, PGE2, NO) at baseline (week 0) and post-treatment (week 16).

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Condition: Osteoarthritis of the Knee

Intervention

• Other: Commercially spearmint tea
  Commercially available, non-selectively bred spearmint tea.
• Other: High Rosmarinic Acid Spearmint Tea
  The investigational product will be a high rosmarinic acid spearmint tea (700B) developed by the Department of Plant Agriculture, University of Guelph. Clone 700B has been selectively bred to contain a rosmarinic acid content 15-20 times greater than that of typical mint.

Study Arms

• Placebo Comparator: Placebo Control
  Participants will consume two cups of commercial spearmint tea per day (300 mL in the morning and 300 mL in the evening, providing a total of approximately 20 mg of rosmarinic acid per day) for a total of 4 months.
  Intervention: Other: Commercially spearmint tea
• Experimental: Experimental
  Participants will consume two cups of a high rosmarinic acid spearmint tea per day (300 mL in the morning and 300 mL in the evening, providing a total of approximately 300 mg of rosmarinic acid per day) for a total of 4 months.
  Intervention: Other: High Rosmarinic Acid Spearmint Tea

• Publications *: Connelly AE, Tucker AJ, Tulk H, Catapang M, Chapman L, Sheikh N, Yurchenko S, Fletcher R, Kott LS, Duncan AM, Wright AJ. High-rosmarinic acid spearmint tea in the management of knee osteoarthritis symptoms. J Med Food. 2014 Dec;17(12):1361-7. doi: 10.1089/jmf.2013.0189.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 21, 2013): 49
• Original Estimated Enrollment (submitted: June 23, 2011): 50
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Is at least 18 years or older
• Have been diagnosed by a health care professional with osteoarthritis of the knee
• Demonstrates a WOMAC pain score greater then 125 at time of study screening

Exclusion Criteria:

• Has any other systemic or rheumatic arthritis
• Has completed or is planning to undergo knee replacement surgery
• Has had a chemical, radiologic, or surgical synovectomy in any large joint within the previous 3 months
• Has any concomitant inflammatory processes such as infectious or rheumatic disease
• Has any gastrointestinal ulcers
• Has any clinically significant, uncontrolled cardiovascular, hepatic, renal, or any other medical condition that may interfere with the study
• Has any serious medication conditions such as recent (within the previous 6 months) heart attack, stroke, cancer and/or diabetes
• Has a recent history (within the previous 6 months) of a clinically significant psychiatric disorder other than mild depression
• Has a known allergy or hypersensitivity to mint or any other food allergies
• Smokes, drinks alcohol (>14 drinks per week) or participates in recreational drug use
• Has participated in a clinical trial involving an investigational or marketed drug within the previous 6 months
• Women who are pregnant or plan to become pregnant during the study period, women who have recently (within the previous 6 months) given birth, women who are currently lactating or have only recently (within the previous 6 months) stopped lactating.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01380015
• Other Study ID Numbers: 11JA040
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Amanda Wright, Ph.D., University of Guelph
• Original Responsible Party: Human Nutraceutical Research Unit
• Current Study Sponsor: University of Guelph
• Original Study Sponsor: Same as current
• Collaborators: Ontario Ministry of Agriculture, Food and Rural Affairs

Investigators

• Principal Investigator: Amanda J Wright, Ph.D.; Human Nutraceutical Research Unit
• Principal Investigator: Alison M Duncan, Ph.D., R.D.; Human Nutraceutical Research Unit

• PRS Account: University of Guelph
• Verification Date: January 2013