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

Primary Purpose

Inflammation, Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
tart cultivar Montmorency cherry juice
placebo cherry fruit drink
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation focused on measuring pain, inflammation, muscle damage

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tart cherry juice

cherry flavored fruit drink

Arm Description

Outcomes

Primary Outcome Measures

Lactate
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
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
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
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.

Full Information

First Posted
February 24, 2012
Last Updated
August 9, 2012
Sponsor
Oregon Health and Science University
Collaborators
Cherry Research Committee
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1. Study Identification

Unique Protocol Identification Number
NCT01547949
Brief Title
Efficacy of Tart Cherry Juice in Reducing Muscle Injury and Biomarkers of Muscle Damage Among Healthy Adults
Official Title
Efficacy of Tart Cherry Juice in Reducing Muscle Injury and Biomarkers of Muscle Damage Among Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Cherry Research Committee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Pain
Keywords
pain, inflammation, muscle damage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tart cherry juice
Arm Type
Experimental
Arm Title
cherry flavored fruit drink
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
tart cultivar Montmorency cherry juice
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo cherry fruit drink
Primary Outcome Measure Information:
Title
Lactate
Description
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.
Time Frame
duration of intervention, average of 18 days per participant
Title
Creatine Kinase
Description
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.
Time Frame
duration of intervention, average of 18 days per participant
Title
Aspartate aminotransferase
Description
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.
Time Frame
duration of intervention, average of 18 days per participant
Title
Lactate dehydrogenase
Description
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.
Time Frame
duration of intervention, average of 18 days per participant
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry S Kuehl, MD, DrPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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