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

NCT01547949 | Completed Phase 4

• 1 other identifier: e7220
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Pain

Keywords

pain; inflammation; muscle damage

Outcome Measures

Primary Outcomes (4)

• 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.

  duration of intervention, average of 18 days per participant

• 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.

  duration of intervention, average of 18 days per participant

• 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.

  duration of intervention, average of 18 days per participant

• 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.

  duration of intervention, average of 18 days per participant

Secondary Outcomes (1)

• Secondary outcomes includes measurement of physical symptoms of exercise-induced muscle damage and soreness as measured by a muscle myometer.

  duration of intervention, average of 18 days per participant

Study Arms (2)

tart cherry juice

EXPERIMENTAL

Dietary Supplement: tart cultivar Montmorency cherry juice

cherry flavored fruit drink

PLACEBO COMPARATOR

Dietary Supplement: placebo cherry fruit drink

Interventions

tart cultivar Montmorency cherry juice DIETARY_SUPPLEMENT

tart cherry juice

placebo cherry fruit drink DIETARY_SUPPLEMENT

cherry flavored fruit drink

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Cherry Research Committee: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Inflammation; Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Kerry S Kuehl, MD, DrPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 8, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 10, 2012

Record last verified: 2012-08

Locations

US (1)