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Completed

NCT Number: NCT01547949

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tart cultivar Montmorency cherry juice

Dietary Supplement

placebo cherry fruit drink

Dietary Supplement

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Cherry Research Committee

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2012
Registry last updated
Aug 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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