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Protein and Recovery From Exercise-induced Muscle Damage

Primary Purpose

Muscle Damage, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protein supplement
Placebo
Sponsored by
Appalachian State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Muscle Damage focused on measuring Muscle damage, Muscle soreness, Muscle function, Innate immune function, Inflammation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • ASU-NCRC Human Performance Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Protein supplementation

Placebo

Arm Description

60 grams protein before, during, after eccentric exercise

60 grams placebo before, during, after eccentric exercise

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Muscle function
Measured pre- and post-eccentric exercise, and each morning during 3 days of recovery. Kneeling medicine ball toss. Vertical jump. Wingate anaerobic power cycling test.
Muscle soreness
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
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
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).

Full Information

First Posted
January 10, 2014
Last Updated
December 12, 2016
Sponsor
Appalachian State University
Collaborators
Herbalife International of America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02034721
Brief Title
Protein and Recovery From Exercise-induced Muscle Damage
Official Title
Influence of Protein-amino Acid Supplementation on Recovery From Exercise-induced Muscle Damage in NASCAR Pit Crew Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Appalachian State University
Collaborators
Herbalife International of America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. 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. Muscle function testing will follow supplementation: vertical jump, kneeling medicine ball toss, and the 30-second Wingate test (see description below). 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. 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. 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: Hammer incline presses with eccentric focus (3 sets, 5 reps). Bench presses with resistance bands (3 sets, 20 seconds to fatigue). Supine medicine ball (9.1 kg) explosive catch and throws (20 seconds, 3 sets). Bent (90○) arm hangs to fatigue (3 sets). Eccentric lat pulls (8 reps, 3 sets). Partner rowing eccentric pulls (8 reps per arm, 3 sets). Eccentric triceps extensions (8 reps per arm, 3 sets). Eccentric bicep curls (8 reps, 3 sets). Explosive tuck jumps (20 seconds, 3 sets). Eccentric back extensions (8 reps, 3 sets). Eccentric hamstring curls (8 reps, 3 sets). 20 second sprints on inclined treadmills with no electrical power (3 sets). Split squats (15 reps each leg, 2 sets). Walk 0.40 km with dumbbells, with shoulder shrugs every three steps. Isometric abdominal curl with medicine ball (9.1 kg) twisting side to side for 20 seconds (3 sets). Abdominal crunches for 20 seconds (3 sets). Plank position (elbows and toes) for 45 seconds (2 sets).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Damage, Inflammation
Keywords
Muscle damage, Muscle soreness, Muscle function, Innate immune function, Inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protein supplementation
Arm Type
Experimental
Arm Description
60 grams protein before, during, after eccentric exercise
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
60 grams placebo before, during, after eccentric exercise
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein supplement
Other Intervention Name(s)
Herbalife Rebuild Strength
Intervention Description
24 g protein before, 12 g during, and 24 g after eccentric exercise
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Muscle damage
Description
Serum myoglobin and creatine kinase will be measured pre- and post-eccentric exercise, and each morning during three days recovery.
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Muscle function
Description
Measured pre- and post-eccentric exercise, and each morning during 3 days of recovery. Kneeling medicine ball toss. Vertical jump. Wingate anaerobic power cycling test.
Time Frame
4 days
Title
Muscle soreness
Description
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).
Time Frame
4 days
Title
Inflammation
Description
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).
Time Frame
4 days
Title
Innate immune function
Description
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).
Time Frame
4 days

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C. Nieman, DrPH
Organizational Affiliation
Appalachian State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASU-NCRC Human Performance Lab
City
Kannapolis
State/Province
North Carolina
ZIP/Postal Code
28081
Country
United States

12. IPD Sharing Statement

Links:
URL
http://ncrc.appstate.edu
Description
Lab site

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Protein and Recovery From Exercise-induced Muscle Damage

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