Polyphenol Rich Supplementation on Markers of Recovery From Intense Resistance Exercise (PRSRE)
Primary Purpose
Muscle Soreness
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tart Cherry
Placebo Oral Capsule [CEBOCAP]
Sponsored by
About this trial
This is an interventional basic science trial for Muscle Soreness focused on measuring Polyphenol rich supplementation, Tart cherry, Lifting, Recovery
Eligibility Criteria
Inclusion Criteria:
- 6 months of resistance training experience with barbel back squat exercise
Exclusion Criteria:
- Not currently taking any antioxidant supplements, not currently using any hormone replacement therapy or anabolic androgenic steroids.
Sites / Locations
- Jacksonville UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Polyphenol Rich Supplement
Arm Description
Rice flour capsule
NordicCherry Tart Cherry Extract Powder 500 mg in capsule form
Outcomes
Primary Outcome Measures
Assessment of Oxidative Stress
Blood analyses will be used, 8 mL of blood will be taken from the participant six times per condition. The blood will be centrifuged to separate the serum/ plasma and analyzed by enzyme- linked immunosorbent assay (ELISA) for c- reactive protein and creatine kinase, and oxidative damage
Secondary Outcome Measures
Muscle soreness
Subjects will mark a line on a 10cm scale that corresponds to the amount of muscular soreness they currently perceive
Vertical Jump Performance
Subjects will be instructed to stand on a NeuroCom Balance Manager forceplate with hands on hips. Subjects will then be instructed to perform 3 consecutive vertical jumps, as high as possible with minimal time between jumps. The jumps will later be assessed for power production.
Full Information
NCT ID
NCT03540602
First Posted
February 26, 2018
Last Updated
May 16, 2018
Sponsor
Jacksonville University
Collaborators
Specnova, inc
1. Study Identification
Unique Protocol Identification Number
NCT03540602
Brief Title
Polyphenol Rich Supplementation on Markers of Recovery From Intense Resistance Exercise
Acronym
PRSRE
Official Title
Polyphenol Rich Supplementation on Markers of Recovery From Intense Resistance Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jacksonville University
Collaborators
Specnova, inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Strength training is commonly used as an intervention to increase muscle mass, thus improving a person's ability to undertake activities of daily living, or enhance athletic performance. The strength training regimen itself, while ultimately having beneficial effects, causes muscle fibers to be damaged, which the body has to recover from. As the body recovers, it rebuilds the muscle tissue and after multiple consecutive bouts of strength training, the muscle eventually becomes larger and stronger. Thus, it is the recovery from strength training exercise that ultimately determines how well the body adapts. Where inadequate recovery could eventually lead to overtraining and/or injury, optimizing the recovery process from strength training could maximize strength training adaptations. This concept of optimizing recovery has led to development of many supplements, including antioxidants, which may reduce the damage associated with strength training activities and therefore enhance positive adaptations. The purpose of this study is to assess the ability of a polyphenol rich supplementation to aid the recovery process from a demanding bout of resistance exercise
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Soreness
Keywords
Polyphenol rich supplementation, Tart cherry, Lifting, Recovery
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
20 male participants will start with a familiarization visit where they will receive either the placebo supplement or the polyphenol rich supplement that they will take for 7 days. After taking the supplement, the participants will come back and run through the acute resistance exercise protocol as well as return the next day for a post test. Next, the participants will undergo a "wash out" phase where they will not take any supplementation. At the end of these 2 weeks, the participants will then take the other supplement (i.e. if they took the polyphenol rich supplement in the first phase they will take the placebo supplement in the second phase). After a week of taking their assigned supplement, participants will complete the acute resistance exercise protocol and the post test.
Masking
ParticipantInvestigator
Masking Description
To ensure that all subjects and researchers are unaware of the treatment assignments we will have one outside individual that will possess the knowledge of which subjects are given which supplement and which were given a placebo. This information will remain confidential until the study has been concluded. At the conclusion of the study, participants will be informed of which condition they were assigned. in an event of an emergency or the participant decides not to participate his condition will be revealed.
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Rice flour capsule
Arm Title
Polyphenol Rich Supplement
Arm Type
Active Comparator
Arm Description
NordicCherry Tart Cherry Extract Powder 500 mg in capsule form
Intervention Type
Dietary Supplement
Intervention Name(s)
Tart Cherry
Other Intervention Name(s)
NordicCherry Tart Cherry Extract Powder 500 mg
Intervention Description
NordicCherry Tart Cherry Extract Powder 500 mg from Specnova, inc
Intervention Type
Other
Intervention Name(s)
Placebo Oral Capsule [CEBOCAP]
Intervention Description
Rice flour
Primary Outcome Measure Information:
Title
Assessment of Oxidative Stress
Description
Blood analyses will be used, 8 mL of blood will be taken from the participant six times per condition. The blood will be centrifuged to separate the serum/ plasma and analyzed by enzyme- linked immunosorbent assay (ELISA) for c- reactive protein and creatine kinase, and oxidative damage
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Muscle soreness
Description
Subjects will mark a line on a 10cm scale that corresponds to the amount of muscular soreness they currently perceive
Time Frame
7 weeks
Title
Vertical Jump Performance
Description
Subjects will be instructed to stand on a NeuroCom Balance Manager forceplate with hands on hips. Subjects will then be instructed to perform 3 consecutive vertical jumps, as high as possible with minimal time between jumps. The jumps will later be assessed for power production.
Time Frame
7 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Must be male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
6 months of resistance training experience with barbel back squat exercise
Exclusion Criteria:
Not currently taking any antioxidant supplements, not currently using any hormone replacement therapy or anabolic androgenic steroids.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Hausenblaus
Phone
904-256-7975
Email
hhausen@ju.edu
First Name & Middle Initial & Last Name or Official Title & Degree
David Hooper
Phone
904-256-7985
Email
dhooper4@ju.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Hausenblaus
Organizational Affiliation
Jacksonville University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacksonville University
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Hausenblaus, PhD
Phone
410-256-7975
Email
hhausen@ju.edu
First Name & Middle Initial & Last Name & Degree
David Hooper, PhD
Phone
904-256-7985
Email
dhooper4@ju.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
11160074
Citation
Reid MB. Invited Review: redox modulation of skeletal muscle contraction: what we know and what we don't. J Appl Physiol (1985). 2001 Feb;90(2):724-31. doi: 10.1152/jappl.2001.90.2.724.
Results Reference
background
PubMed Identifier
3202155
Citation
Alessio HM, Goldfarb AH, Cutler RG. MDA content increases in fast- and slow-twitch skeletal muscle with intensity of exercise in a rat. Am J Physiol. 1988 Dec;255(6 Pt 1):C874-7. doi: 10.1152/ajpcell.1988.255.6.C874.
Results Reference
result
PubMed Identifier
11427763
Citation
Blair SN, Cheng Y, Holder JS. Is physical activity or physical fitness more important in defining health benefits? Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S379-99; discussion S419-20. doi: 10.1097/00005768-200106001-00007.
Results Reference
result
PubMed Identifier
18923182
Citation
Powers SK, Jackson MJ. Exercise-induced oxidative stress: cellular mechanisms and impact on muscle force production. Physiol Rev. 2008 Oct;88(4):1243-76. doi: 10.1152/physrev.00031.2007.
Results Reference
result
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Polyphenol Rich Supplementation on Markers of Recovery From Intense Resistance Exercise
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