NCT03540602

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

February 26, 2018

Last Update Submit

May 16, 2018

Conditions

Keywords

Polyphenol rich supplementationTart cherryLiftingRecovery

Outcome Measures

Primary Outcomes (1)

  • 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

    7 weeks

Secondary Outcomes (2)

  • Muscle soreness

    7 weeks

  • Vertical Jump Performance

    7 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Rice flour capsule

Other: Placebo Oral Capsule [CEBOCAP]

Polyphenol Rich Supplement

ACTIVE COMPARATOR

NordicCherry Tart Cherry Extract Powder 500 mg in capsule form

Dietary Supplement: Tart Cherry

Interventions

Tart CherryDIETARY_SUPPLEMENT

NordicCherry Tart Cherry Extract Powder 500 mg from Specnova, inc

Also known as: NordicCherry Tart Cherry Extract Powder 500 mg
Polyphenol Rich Supplement

Rice flour

Placebo

Eligibility Criteria

Age21 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMust be male
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • months of resistance training experience with barbel back squat exercise

You may not qualify if:

  • Not currently taking any antioxidant supplements, not currently using any hormone replacement therapy or anabolic androgenic steroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacksonville University

Jacksonville, Florida, 32211, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 11160074BACKGROUND
  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Myalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Heather Hausenblaus

    Jacksonville University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Hausenblaus

CONTACT

David Hooper

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

May 30, 2018

Study Start

May 1, 2018

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations