- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03448328
Pea Protein Supplementation and Muscle Damage
Influence of Pea Protein Supplementation on Recovery From Exercise-induced Muscle Damage
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
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Kannapolis, North Carolina, United States, 28081
- Appalachian State University Human Performance Lab, North Carolina Research Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pea Protein
NUTRALYS pea protein supplement
|
0.3 grams of protein per kilogram of body weight before and after eccentric exercise, and each of 4 mornings of recovery
|
Experimental: Whey Protein
Whey protein supplement
|
0.3 grams of protein per kilogram of body weight before and after eccentric exercise, and each of 4 mornings of recovery
|
Active Comparator: Apple juice
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1.2 calories per kilogram body weight before and after eccentric exercise, and each of 4 mornings of recovery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Myoglobin
Time Frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
|
Muscle damage marker
|
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)
|
Muscle damage marker
|
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)
|
Self-reported perception of muscle soreness, 1-10 scale
|
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)
|
Muscle performance, vertical jump height
|
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)
|
Muscle performance, bench press to exhaustion with weighted bar (75% body weight for men, 50% for women)
|
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)
|
Muscle performance, leg-back strength with a dynamometer
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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)
|
Anaerobic power cycling test, peak and average anaerobic power
|
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)
|
Inflammation measurement
|
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)
|
IL-6, IL-8, IL-10, MCP-1, IL-1ra, GCSF
|
Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David C Nieman, DrPH, Appalachian State Univ
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 18-0165
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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