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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01547949
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : August 10, 2012
Sponsor:
Collaborator:
Cherry Research Committee
Information provided by (Responsible Party):
Kerry Kuehl, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE February 24, 2012
First Posted Date  ICMJE March 8, 2012
Last Update Posted Date August 10, 2012
Study Start Date  ICMJE March 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2012)
  • Lactate [ Time Frame: duration of intervention, average of 18 days per participant ]
    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 ]
    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 ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01547949 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2012)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Tart Cherry Juice in Reducing Muscle Injury and Biomarkers of Muscle Damage Among Healthy Adults
Official Title  ICMJE Efficacy of Tart Cherry Juice in Reducing Muscle Injury and Biomarkers of Muscle Damage Among Healthy Adults
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Inflammation
  • Pain
Intervention  ICMJE
  • Dietary Supplement: tart cultivar Montmorency cherry juice
  • Dietary Supplement: placebo cherry fruit drink
Study Arms  ICMJE
  • Experimental: tart cherry juice
    Intervention: Dietary Supplement: tart cultivar Montmorency cherry juice
  • Placebo Comparator: cherry flavored fruit drink
    Intervention: Dietary Supplement: placebo cherry fruit drink
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 5, 2012)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01547949
Other Study ID Numbers  ICMJE e7220
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kerry Kuehl, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Cherry Research Committee
Investigators  ICMJE
Principal Investigator: Kerry S Kuehl, MD, DrPH Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP