Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Protein and Recovery From Exercise-induced Muscle Damage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034721
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : December 13, 2016
Sponsor:
Collaborator:
Herbalife International of America, Inc.
Information provided by (Responsible Party):
Appalachian State University

Tracking Information
First Submitted Date  ICMJE January 10, 2014
First Posted Date  ICMJE January 13, 2014
Last Update Posted Date December 13, 2016
Study Start Date  ICMJE December 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
Muscle damage [ Time Frame: 4 days ]
Serum myoglobin and creatine kinase will be measured pre- and post-eccentric exercise, and each morning during three days recovery.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
  • Muscle function [ Time Frame: 4 days ]
    Measured pre- and post-eccentric exercise, and each morning during 3 days of recovery.
    1. Kneeling medicine ball toss.
    2. Vertical jump.
    3. Wingate anaerobic power cycling test.
  • Muscle soreness [ Time Frame: 4 days ]
    Measured pre- and post-eccentric exercise, and during each morning during 3 days recovery. DOMS will be self-reported by the subjects using a 10-point Likert-scale questionnaire (Res Quart Exerc Sport 1993;64:103-107).
  • Inflammation [ Time Frame: 4 days ]
    Measured from blood samples taken pre- and post-eccentric exercise, and each morning during 3 days recovery. Serum C-reactive protein (CRP) will be analyzed by the clinical hematology laboratory at the Carolina Medical Center (Charlotte, NC). CRP will be measured using an LX-20 clinical analyzer (Beckman Coulter Electronics, Brea, CA). Total plasma concentrations of interleukin-6 will be determined using an electrochemiluminescence based solid-phase sandwich immunoassay (Meso Scale Discovery, Gaithersburg, MD).
  • Innate immune function [ Time Frame: 4 days ]
    Will be measured from blood samples taken pre- and post-eccentric exercise, and each morning during 3 days of recovery. Granulocyte and monocyte phagocytosis (G-PHAG, M-PHAG), and oxidative burst activity (G-OBA, M-OBA) will be assayed at the immunology laboratory at UNC-Charlotte (Dr. Didier Dreau).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protein and Recovery From Exercise-induced Muscle Damage
Official Title  ICMJE Influence of Protein-amino Acid Supplementation on Recovery From Exercise-induced Muscle Damage in NASCAR Pit Crew Athletes
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).
Detailed Description

Intense, eccentric resistance exercise produces high mechanical forces leading to muscle damage, soreness, inflammation, and a loss of muscle function (J Sci Med Sport 2010;13:178-181). Limited evidence suggests that protein-amino acid supplementation before, during, and following damaging resistance exercise reduces muscle damage and accelerates recovery in resistance trained subjects (J Int Soc Sports Nutr 2012;9:20; Int J Sport Nutr Exerc Metab 2010;20:236-44; Appl Physiol Nutr Metab 2008;33:483-8).

Herbalife 24 Rebuild Strength is a protein-amino acid supplement recommended for use after resistance exercise to help rebuild muscle, speed recovery, support immune function, and promote muscle repair. (http://performancenutrition.herbalife.com/en/products/ rebuild-strength). A serving of Rebuild Strength (50.5 grams) contains 190 kilocalories, 24 grams of protein, 18 grams of carbohydrate, 1 gram of fat, and vitamins and minerals (C, E, B1, B6, B12, pantothenic acid, calcium, iron, magnesium, chromium, sodium, potassium, all at 10% to 150% Daily Value levels). The 24 grams of protein per serving include whey and casein proteins, L-glutamine (3,000 mg), and branched-chain amino acids (BCAA) (4,000 mg). (See nutrition label at the website).

Purpose: To determine if supplementation with Herbalife 24 Rebuild Strength (compared to placebo) before, during, and after a 90-minute bout of eccentric exercise can attenuate exercise-induced muscle damage, inflammation, and delayed onset of muscle soreness (DOMS), speed recovery of muscle function, and maintain innate immune function in NASCAR pit crew athletes (Hendrick Motor Sports).

Research design:

Subjects will be randomized to Rebuild Strength or placebo supplements (double blind administration in the same colored bottles, with the code held by Herbalife until the study is completed).

Testing Sequence:

  1. Subjects will come to the HMS training facility in an overnight fasted state (no food or beverage other than water for the previous 8 hours) and provide a DOMS rating and a blood sample. Height, weight, and percent body fat (skinfolds) will also be obtained.
  2. Rebuild Strength subjects will consume 2 scoops (50.5 grams of product with 24 grams protein) in water 15-20 min prior to the 90-min eccentric exercise bout. Subjects in the placebo group will consume 2 scoops of the same supplement but without protein or amino acids (with carbohydrate added to keep energy intake the same between groups). Supplements will be prepared by Herbalife and coded "A" and "B", with this double blind code maintained until the study has been completed.
  3. Muscle function testing will follow supplementation: vertical jump, kneeling medicine ball toss, and the 30-second Wingate test (see description below).
  4. Subjects will engage in 90-min eccentric exercise (see description below), with 1 scoop of Rebuild Strength (12 grams protein) or placebo ingested after 45 min exercise.
  5. Immediately following exercise, subjects will ingest 2 scoops Rebuild Strength (24 grams protein) or placebo, provide a DOMS rating and a blood sample, and then take the same three muscle function tests. Total protein intake before, during, and immediately after the 90-min eccentric exercise bout will be 60 grams. All subjects will refrain from any food or beverage intake (except for water) for one hour after taking the final supplement dose.
  6. Subjects will return at 7 am in an overnight fasted state three days in a row after the eccentric exercise bout, and will provide a DOMS rating and a blood sample followed by ingestion of 2 scoops Rebuild Strength or placebo, and then the three muscle function tests. Subjects will engage in normal training during the 3-day recovery period. The blood samples will be analyzed for markers of muscle damage, inflammation, and immune function.

Eccentric Exercise Bout:

HMS pit crew members engage in eccentric exercise bouts on a regular basis, and are very familiar with the exercises that will be utilized in this study to induce muscle damage and soreness. The 90-minute eccentric exercise bout will consist of 17 different exercises:

  1. Hammer incline presses with eccentric focus (3 sets, 5 reps).
  2. Bench presses with resistance bands (3 sets, 20 seconds to fatigue).
  3. Supine medicine ball (9.1 kg) explosive catch and throws (20 seconds, 3 sets).
  4. Bent (90○) arm hangs to fatigue (3 sets).
  5. Eccentric lat pulls (8 reps, 3 sets).
  6. Partner rowing eccentric pulls (8 reps per arm, 3 sets).
  7. Eccentric triceps extensions (8 reps per arm, 3 sets).
  8. Eccentric bicep curls (8 reps, 3 sets).
  9. Explosive tuck jumps (20 seconds, 3 sets).
  10. Eccentric back extensions (8 reps, 3 sets).
  11. Eccentric hamstring curls (8 reps, 3 sets).
  12. 20 second sprints on inclined treadmills with no electrical power (3 sets).
  13. Split squats (15 reps each leg, 2 sets).
  14. Walk 0.40 km with dumbbells, with shoulder shrugs every three steps.
  15. Isometric abdominal curl with medicine ball (9.1 kg) twisting side to side for 20 seconds (3 sets).
  16. Abdominal crunches for 20 seconds (3 sets).
  17. Plank position (elbows and toes) for 45 seconds (2 sets).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Muscle Damage
  • Inflammation
Intervention  ICMJE
  • Dietary Supplement: Protein supplement
    24 g protein before, 12 g during, and 24 g after eccentric exercise
    Other Name: Herbalife Rebuild Strength
  • Dietary Supplement: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Protein supplementation
    60 grams protein before, during, after eccentric exercise
    Intervention: Dietary Supplement: Protein supplement
  • Placebo Comparator: Placebo
    60 grams placebo before, during, after eccentric exercise
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Heart problem or told by an MD not to engage in vigorous exercise
  • History of allergies to milk or soy products
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02034721
Other Study ID Numbers  ICMJE 14-0098
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Appalachian State University
Study Sponsor  ICMJE Appalachian State University
Collaborators  ICMJE Herbalife International of America, Inc.
Investigators  ICMJE
Principal Investigator: David C. Nieman, DrPH Appalachian State University
PRS Account Appalachian State University
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP