NCT02034721

Brief Summary

Intense, eccentric resistance exercise causes muscle damage, soreness, inflammation, and a loss of muscle function. Protein-amino acid supplementation before, during, and following damaging resistance exercise may reduce muscle damage and accelerate recovery. This study will determine if supplementation with Herbalife 24 Rebuild Strength (compared to placebo) before, during, and after a 90-minute bout of eccentric exercise attenuates exercise-induced muscle damage, inflammation, and delayed onset of muscle soreness (DOMS), speeds recovery of muscle function, and maintains immune function in NASCAR pit crew athletes (Hendrick Motor Sports).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 13, 2016

Status Verified

January 1, 2015

Enrollment Period

2 months

First QC Date

January 10, 2014

Last Update Submit

December 12, 2016

Conditions

Muscle DamageInflammation

Keywords

Muscle damageMuscle sorenessMuscle functionInnate immune functionInflammation

Outcome Measures

Primary Outcomes (1)

  • Muscle damage

    Serum myoglobin and creatine kinase will be measured pre- and post-eccentric exercise, and each morning during three days recovery.

    4 days

Secondary Outcomes (4)

  • Muscle function

    4 days

  • Muscle soreness

    4 days

  • Inflammation

    4 days

  • Innate immune function

    4 days

Study Arms (2)

Protein supplementation

EXPERIMENTAL

60 grams protein before, during, after eccentric exercise

Dietary Supplement: Protein supplement

Placebo

PLACEBO COMPARATOR

60 grams placebo before, during, after eccentric exercise

Dietary Supplement: Placebo

Interventions

Protein supplementDIETARY_SUPPLEMENT

24 g protein before, 12 g during, and 24 g after eccentric exercise

Also known as: Herbalife Rebuild Strength
Protein supplementation
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • NASCAR pit crew members/recruits from Hendrick Motorsports
  • Agree to avoid use of other protein supplements during the 4-day study

You may not qualify if:

  • Heart problem or told by an MD not to engage in vigorous exercise
  • History of allergies to milk or soy products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASU-NCRC Human Performance Lab

Kannapolis, North Carolina, 28081, United States

Location

Related Links

MeSH Terms

Conditions

InflammationMyalgia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • David C. Nieman, DrPH

    Appalachian State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 13, 2014

Study Start

December 1, 2013

Primary Completion

February 1, 2014

Study Completion

December 1, 2014

Last Updated

December 13, 2016

Record last verified: 2015-01

Locations

US(1)