Efficacy of Spearmint Tea in Relieving Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Collaborator:
Ontario Ministry of Agriculture, Food and Rural Affairs
Information provided by (Responsible Party):
Amanda Wright, Ph.D., University of Guelph
ClinicalTrials.gov Identifier:
NCT01380015
First received: June 21, 2011
Last updated: January 21, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Knee
Other: Commercially spearmint tea
Other: High Rosmarinic Acid Spearmint Tea
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by University of Guelph:

Primary Outcome Measures:
  • Self-reported ratings of pain and physical function [ Time Frame: Four months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Performance-based measures of physical function [ Time Frame: Four months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 49
Study Start Date: July 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Commercially spearmint tea
Commercially available, non-selectively bred 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.
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380015

Locations
Canada, Ontario
Human Nutraceutical Research Unit, University of Guelph
Guelph, Ontario, Canada, N1G2W1
University of Guelph
Guelph, Ontario, Canada, N1G 2W1
Sponsors and Collaborators
University of Guelph
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
  More Information

No publications provided

Responsible Party: Amanda Wright, Ph.D., Director, HNRU, University of Guelph
ClinicalTrials.gov Identifier: NCT01380015     History of Changes
Other Study ID Numbers: 11JA040
Study First Received: June 21, 2011
Last Updated: January 21, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Guelph:
osteoarthritis
spearmint
rosmarinic acid

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Rosmarinic acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Platelet Aggregation Inhibitors
Hematologic Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014