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Muscle DamageNCT02034721

Protein and Recovery From Exercise-induced Muscle Damage

A study testing Protein supplement in people with Muscle Damage and Inflammation, run by Appalachian State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, men onlyHealthy volunteers can take part
Conditions the study is for
Muscle Damage, Inflammation
What is being tested?
Protein supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
Dec 2013to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • ASU-NCRC Human Performance Lab

    Kannapolis, North Carolina, 28081

Other trials in United States

About this study

Official title: Influence of Protein-amino Acid Supplementation on Recovery From Exercise-induced Muscle Damage in NASCAR Pit Crew Athletes

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).

Read the 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).
Being tested
Protein supplement, Placebo
Keywords
Muscle damage, Muscle soreness, Muscle function, Innate immune function, Inflammation
Medical subject headings
Inflammation, Myalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Protein supplementDietary supplement

    Also called Herbalife Rebuild Strength

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

  • PlaceboDietary supplement

    Placebo

Study groups in NCT02034721
Study groupRoleWhat they receive
Protein supplementationExperimental60 grams protein before, during, after eccentric exercise
Receives: Dietary Supplement: Protein supplement
PlaceboPlacebo comparator60 grams placebo before, during, after eccentric exercise
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle damage

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

    Measured: 4 days

Secondary outcomes (4)
  1. Muscle function

    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.

    Measured: 4 days

  2. 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).

    Measured: 4 days

  3. 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).

    Measured: 4 days

  4. 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).

    Measured: 4 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionFeb 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02034721
Sponsor's protocol ID
14-0098
Status last verified
Jan 2015
First submitted
10 Jan 2014
Last updated
13 Dec 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Protein supplement in people with Muscle Damage and Inflammation, run by Appalachian State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle damage (time frame: 4 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2016.

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