Muscular InjuryNCT03448328
Pea Protein Supplementation and Muscle Damage
A study testing NUTRALYS pea protein supplement, Whey Protein and Apple juice in people with Muscular Injury, run by Appalachian State University at 1 site in United States.
Trial summary
The purpose of this study is to determine if supplementation with NUTRALYS pea protein isolate compared to whey protein and apple juice (carbohydrate, non-protein control) before, during, and after a 90-minute bout of eccentric exercise can attenuate exercise-induced muscle damage, inflammation, and delayed onset of… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscular Injury
- What is being tested?
- NUTRALYS pea protein supplement, Whey Protein and Apple juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2018to 1 Jun 2020
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, female, 18 to 55 years of age.
- Non-athlete, and not engaged in regular resistance training (less than 3 sessions per week).
- BMI under 30 (non-obese).
- At "low risk" status for cardiovascular disease (as determined with a screening questionnaire).
- Agree to avoid the use of protein and large-dose vitamin/mineral supplements (above 100% of recommended dietary allowances), herbs, and all medications (in particular, NSAIDs such as ibuprofen and aspirin) during the week of the project.
Who cannot join
- Inability to comply with study requirements.
- Any other concurrent condition which, in the opinion of the primary investigator (PI), would preclude participation in this study or interfere with compliance.
- Current, active history of coronary heart disease, stroke, cancer, diabetes, rheumatoid arthritis, high blood pressure, kidney disease, liver disease, blood disease, hormonal disease, or metabolic disease.
- History of cancer in the 5 years prior to the screening visit (except skin or cervical cancer that was successfully treated).
- Current use of any type of medication (or unwillingness to stop use of over-the-counter medications two weeks before the start of the study).
- Recent history of musculoskeletal trauma (fracture, strain, sprain, etc.) that has not fully healed prior to baseline testing.
- Females: pregnant or breastfeeding; or body weight under 100 pounds.
Trial locations and contacts
1 site in 1 country.
United States1 site
Appalachian State University Human Performance Lab, North Carolina Research Campus
Kannapolis, North Carolina, 28081
About this study
Official title: Influence of Pea Protein Supplementation on Recovery From Exercise-induced Muscle Damage
The purpose of this study is to determine if supplementation with NUTRALYS pea protein isolate compared to whey protein and apple juice (carbohydrate, non-protein control) 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), and speed recovery of muscle function.
Read the detailed description
Study participants will be randomized to the NUTRALYS pea protein supplement, whey protein, or apple juice (parallel group design). Study participants will come to the lab at 7:00 am Monday through Friday in an overnight fasted state and provide a blood sample (maximum of 30 ml or two tablespoons). The blood samples will be analyzed for various measures of muscle damage and inflammation, and extra samples will be stored for additional measurements depending on funding.
After the blood draw, participants will provide a muscle soreness rating. Next, the two protein sources (pea and whey protein), will be consumed at a weight adjusted amount (0.3 grams of protein per kilogram of body weight), and administered under double blind procedures. The amount of apple juice will be adjusted to body weight (1.2 calories per kilogram body weight).
Four muscle function tests will be conducted: vertical jump, bench press, leg-back strength, and anaerobic power through the 30-second Wingate test. These performance tests will be administered before and after the 90-minute eccentric muscle exercise bout, and each of the following four mornings of recovery.
After taking the four performance tests, participants will engage in 90-minutes of eccentric exercise. Immediately following exercise, participants will provide a muscle soreness rating and a blood sample, ingest another protein dose (0.3 g/kg) (or apple juice), and then take the four muscle function tests. Participants will return at 7 am in an overnight fasted state four days in a row after the eccentric exercise bout, and provide muscle soreness ratings and blood samples followed by ingestion of the protein supplements or apple juice. Following ingestion of the supplements, participants will take the four muscle function tests.
- Conditions
- Muscular Injury
- Being tested
- NUTRALYS pea protein supplement, Whey Protein, Apple juice
- Keywords
- muscular strength, inflammation, protein
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUTRALYS pea protein supplementDietary supplement
0.3 grams of protein per kilogram of body weight before and after eccentric exercise, and each of 4 mornings of recovery
Whey ProteinDietary supplement
0.3 grams of protein per kilogram of body weight before and after eccentric exercise, and each of 4 mornings of recovery
Apple juiceDietary supplement
1.2 calories per kilogram body weight before and after eccentric exercise, and each of 4 mornings of recovery
| Study group | Role | What they receive |
|---|---|---|
| Pea Protein | Experimental | NUTRALYS pea protein supplement Receives: Dietary Supplement: NUTRALYS pea protein supplement |
| Whey Protein | Experimental | Whey protein supplement Receives: Dietary Supplement: Whey Protein |
| Apple juice | Active comparator | Apple juice Receives: Dietary Supplement: Apple juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Creatine kinase
Muscle damage marker
Measured: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Secondary outcomes (9)
Serum Myoglobin
Muscle damage marker
Measured: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Serum Lactate Dehydrogenase
Muscle damage marker
Measured: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Delayed onset of muscle soreness
Self-reported perception of muscle soreness, 1-10 scale
Measured: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Vertical jump
Muscle performance, vertical jump height
Measured: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Bench press
Muscle performance, bench press to exhaustion with weighted bar (75% body weight for men, 50% for women)
Measured: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Leg-back strength
Muscle performance, leg-back strength with a dynamometer
Measured: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
30-second Wingate cycle test
Anaerobic power cycling test, peak and average anaerobic power
Measured: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Serum C-reactive protein
Inflammation measurement
Measured: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Plasma cytokine panel
IL-6, IL-8, IL-10, MCP-1, IL-1ra, GCSF
Measured: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start5 Mar 2018
- Primary completion15 Feb 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular InjuryStudies 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
- Model description
- Randomized, parallel group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Collaborators
- Roquette Freres
- Responsible party
- Sponsor
- Investigators
- David C Nieman, DrPH, Principal investigator, Appalachian State Univ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448328
- Sponsor's protocol ID
- 18-0165
- Status last verified
- Jul 2020
- First submitted
- 22 Feb 2018
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Depends on the journal where the paper will be published.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pea Protein Supplementation on Recovery From Exercise-induced Muscle Damage
- ClinicalTrials.gov ID
- NCT03448328
- Acronym / sponsor ID
- 18-0165
- Conditions
- Muscular Injury
- Keywords
- muscular strength, inflammation, protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Collaborators
- Roquette Freres
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 28 Feb 2018 (actual)
- 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.
The purpose of this study is to determine if supplementation with NUTRALYS pea protein isolate compared to whey protein and apple juice (carbohydrate, non-protein control) 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), and speed recovery of muscle function.
Detailed description
Study participants will be randomized to the NUTRALYS pea protein supplement, whey protein, or apple juice (parallel group design). Study participants will come to the lab at 7:00 am Monday through Friday in an overnight fasted state and provide a blood sample (maximum of 30 ml or two tablespoons). The blood samples will be analyzed for various measures of muscle damage and inflammation, and extra samples will be stored for additional measurements depending on funding.
After the blood draw, participants will provide a muscle soreness rating. Next, the two protein sources (pea and whey protein), will be consumed at a weight adjusted amount (0.3 grams of protein per kilogram of body weight), and administered under double blind procedures. The amount of apple juice will be adjusted to body weight (1.2 calories per kilogram body weight).
Four muscle function tests will be conducted: vertical jump, bench press, leg-back strength, and anaerobic power through the 30-second Wingate test. These performance tests will be administered before and after the 90-minute eccentric muscle exercise bout, and each of the following four mornings of recovery.
After taking the four performance tests, participants will engage in 90-minutes of eccentric exercise. Immediately following exercise, participants will provide a muscle soreness rating and a blood sample, ingest another protein dose (0.3 g/kg) (or apple juice), and then take the four muscle function tests. Participants will return at 7 am in an overnight fasted state four days in a row after the eccentric exercise bout, and provide muscle soreness ratings and blood samples followed by ingestion of the protein supplements or apple juice. Following ingestion of the supplements, participants will take the four muscle function tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, parallel group
| Arm | Type | Receives |
|---|---|---|
| Pea Protein | Experimental | Dietary Supplement: NUTRALYS pea protein supplementNUTRALYS pea protein supplement |
| Whey Protein | Experimental | Dietary Supplement: Whey ProteinWhey protein supplement |
| Apple juice | Active comparator | Dietary Supplement: Apple juiceApple juice |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male, female, 18 to 55 years of age.
- Non-athlete, and not engaged in regular resistance training (less than 3 sessions per week).
- BMI under 30 (non-obese).
- At "low risk" status for cardiovascular disease (as determined with a screening questionnaire).
- Agree to avoid the use of protein and large-dose vitamin/mineral supplements (above 100% of recommended dietary allowances), herbs, and all medications (in particular, NSAIDs such as ibuprofen and aspirin) during the week of the project.
Key exclusion criteria (7 listed)
- Inability to comply with study requirements.
- Any other concurrent condition which, in the opinion of the primary investigator (PI), would preclude participation in this study or interfere with compliance.
- Current, active history of coronary heart disease, stroke, cancer, diabetes, rheumatoid arthritis, high blood pressure, kidney disease, liver disease, blood disease, hormonal disease, or metabolic disease.
- History of cancer in the 5 years prior to the screening visit (except skin or cervical cancer that was successfully treated).
- Current use of any type of medication (or unwillingness to stop use of over-the-counter medications two weeks before the start of the study).
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 |
|---|---|---|
| NUTRALYS pea protein supplement0.3 grams of protein per kilogram of body weight before and after eccentric exercise, and each of 4 mornings of recovery | Dietary supplement | Pea Protein |
| Whey Protein0.3 grams of protein per kilogram of body weight before and after eccentric exercise, and each of 4 mornings of recovery | Dietary supplement | Whey Protein |
| Apple juice1.2 calories per kilogram body weight before and after eccentric exercise, and each of 4 mornings of recovery | Dietary supplement | Apple juice |
Primary outcome
Serum Creatine kinase
Time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Muscle damage marker
9 secondary outcomes
Serum Myoglobin
Time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Serum Lactate Dehydrogenase
Time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Delayed onset of muscle soreness
Time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Vertical jump
Time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Bench press
Time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Leg-back strength
Time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
30-second Wingate cycle test
Time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Serum C-reactive protein
Time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Plasma cytokine panel
Time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
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 15 Jul 2020.
- Individual participant dataSharing planned: No. Depends on the journal where the paper will be published.
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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 Univ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUTRALYS pea protein supplement, Whey Protein and Apple juice in people with Muscular Injury, 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 5 inclusion and 7 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 15 Jul 2020. 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. 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?
Serum Creatine kinase (time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)). 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 15 Jul 2020.