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.
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
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:
- 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).
- Conditions
- Muscle Damage, Inflammation
- 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 group | Role | What they receive |
|---|---|---|
| Protein supplementation | Experimental | 60 grams protein before, during, after eccentric exercise Receives: Dietary Supplement: Protein supplement |
| Placebo | Placebo comparator | 60 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.
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)
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.
Measured: 4 days
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
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
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.
- First posted13 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionFeb 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Collaborators
- Herbalife International of America, Inc.
- Responsible party
- Sponsor
- Investigators
- David C. Nieman, DrPH, Principal investigator, Appalachian State University
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Protein-amino Acid Supplementation on Recovery From Exercise-induced Muscle Damage in NASCAR Pit Crew Athletes
- ClinicalTrials.gov ID
- NCT02034721
- Acronym / sponsor ID
- 14-0098
- Conditions
- Muscle Damage, Inflammation
- Keywords
- Muscle damage, Muscle soreness, Muscle function, Innate immune function, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Collaborators
- Herbalife International of America, Inc.
- Study start
- Dec 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein supplementation | Experimental | Dietary Supplement: Protein supplement60 grams protein before, during, after eccentric exercise |
| Placebo | Placebo comparator | Dietary Supplement: Placebo60 grams placebo before, during, after eccentric exercise |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- NASCAR pit crew members/recruits from Hendrick Motorsports
- Agree to avoid use of other protein supplements during the 4-day study
Key exclusion criteria (2 listed)
- Heart problem or told by an MD not to engage in vigorous exercise
- History of allergies to milk or soy products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein supplementAlso: Herbalife Rebuild Strength24 g protein before, 12 g during, and 24 g after eccentric exercise | Dietary supplement | Protein supplementation |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
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.
4 secondary outcomes
Muscle function
Time frame: 4 days
Muscle soreness
Time frame: 4 days
Inflammation
Time frame: 4 days
Innate immune function
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Lab siteLink provided by the sponsor.
Related trials for Muscle Damage
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Not yet recruiting
Effects of Manual Lymphatic Drainage and Pressotherapy on Muscle Recovery After Eccentric Exercise in Physically Active Young Adults
Young Athletes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C. Nieman, DrPH principal investigator
Appalachian State University
1 site in 1 country: see every site and its status.
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.