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Efficacy of Tart Cherry Juice in Reducing Muscle Injury and Biomarkers of Muscle Damage Among Healthy Adults

This study has been completed.
Sponsor:
Collaborator:
Cherry Research Committee
Information provided by (Responsible Party):
Kerry Kuehl, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01547949
First received: February 24, 2012
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to assess the effects of tart cherry juice to reduce serum biomarkers of inflammation and reduce muscle soreness in healthy adults who undergo a bout of controlled eccentric exercise.


Condition Intervention Phase
Inflammation
Pain
 Dietary Supplement: tart cultivar Montmorency cherry juice
Dietary Supplement: placebo cherry fruit drink
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Tart Cherry Juice in Reducing Muscle Injury and Biomarkers of Muscle Damage Among Healthy Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Lactate [ Time Frame: duration of intervention, average of 18 days per participant ] [ Designated as safety issue: No ]
    Primary outcomes include measurement of serum and plasma biomarkers that provide a generalized measurement of inflammatory activity; these include Creatine Kinase (CK), Aspartate aminotransferase (AST), Lactate dehydrogenase (LDH), and lactate.

  • Creatine Kinase [ Time Frame: duration of intervention, average of 18 days per participant ] [ Designated as safety issue: No ]
    Primary outcomes include measurement of serum and plasma biomarkers that provide a generalized measurement of inflammatory activity; these include Creatine Kinase (CK), Aspartate aminotransferase (AST), Lactate dehydrogenase (LDH), and lactate.

  • Aspartate aminotransferase [ Time Frame: duration of intervention, average of 18 days per participant ] [ Designated as safety issue: No ]
    Primary outcomes include measurement of serum and plasma biomarkers that provide a generalized measurement of inflammatory activity; these include Creatine Kinase (CK), Aspartate aminotransferase (AST), Lactate dehydrogenase (LDH), and lactate.

  • Lactate dehydrogenase [ Time Frame: duration of intervention, average of 18 days per participant ] [ Designated as safety issue: No ]
    Primary outcomes include measurement of serum and plasma biomarkers that provide a generalized measurement of inflammatory activity; these include Creatine Kinase (CK), Aspartate aminotransferase (AST), Lactate dehydrogenase (LDH), and lactate.


Secondary Outcome Measures:
  • Secondary outcomes includes measurement of physical symptoms of exercise-induced muscle damage and soreness as measured by a muscle myometer. [ Time Frame: duration of intervention, average of 18 days per participant ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: March 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tart cherry juice Dietary Supplement: tart cultivar Montmorency cherry juice
Placebo Comparator: cherry flavored fruit drink Dietary Supplement: placebo cherry fruit drink

Detailed Description:

Numerous antioxidant and anti-inflammatory agents have been identified in tart cherries, and a study among healthy, non-exercising individuals demonstrated that tart cherries decreased post-exercise weakness and muscle pain. The purpose of this study is to assess the analgesic and myoprotective effects of tart cherry juice among healthy subjects in a randomized, placebo controlled, double-blind, crossover design trial. Fifteen healthy individuals will perform a bout of eccentric elbow flexion contractions (2 x 10 near maximum), and will then ingest 10 fl oz of a cherry juice or a placebo juice twice a day for four days, beginning immediately post exercise. Before and after exercise, and for three days following the eccentric exercise, blood will be drawn to measure serum biomarkers of muscle damage and muscle soreness will be recorded. The protocol will be repeated after a 9-10 day washout period with subjects consuming the alternative juice for the second trial. The opposite arm will perform the eccentric exercise for the second bout to avoid the repeated bout protective effect. The study's outcomes are 1) to assess changes in serum biomarkers of muscle damage, and 2) to assess changes in muscle soreness.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • no regular upper body strength training
  • no elbow flexor pain, no history of elbow or shoulder injury
  • ability and willingness not to take any anti-inflammatory or pain relieving drugs during the course of the study, not to seek any other treatment for any symptoms of muscle damage directly resulting from the exercises performed as part of the study, and not to exercise their upper extremities during the study.

Exclusion Criteria:

  • individuals who have used or are using antiepileptic drugs for pain, acupuncture, or transcutaneous electrical nerve stimulation within 3 weeks before enrollment
  • recent use (within 5 half-lives) of topical medications/anesthetics, muscle relaxants, tender point anesthetic injections within 2 months
  • systemic steroid use within 3 months
  • any investigational drug/device use in the prior 30 days
  • individuals who have Type 1 or Type 2 Diabetes
  • individuals who are pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547949

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Cherry Research Committee
Investigators
Principal Investigator: Kerry S Kuehl, MD, DrPH Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Kerry Kuehl, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01547949     History of Changes
Other Study ID Numbers: e7220
Study First Received: February 24, 2012
Last Updated: August 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
pain
inflammation
muscle damage

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013