An interventional study of NUTRALYS pea protein supplement and Whey Protein in Muscular Injury, sponsored by Appalachian State University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-15.
Sponsored by Appalachian State University · Not applicable, Interventional, and Prevention
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.
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.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 90 is above the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation studies →Appalachian State University is the lead sponsor of 41 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NUTRALYS pea protein supplement
Dietary Supplement: NUTRALYS pea protein supplement
Whey protein supplement
Dietary Supplement: Whey Protein
Apple juice
Dietary Supplement: Apple juice
0.3 grams of protein per kilogram of body weight before and after eccentric exercise, and each of 4 mornings of recovery
0.3 grams of protein per kilogram of body weight before and after eccentric exercise, and each of 4 mornings of recovery
1.2 calories per kilogram body weight before and after eccentric exercise, and each of 4 mornings of recovery
Serum Creatine kinase
Muscle damage marker
Time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Serum Myoglobin
Muscle damage marker
Time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Serum Lactate Dehydrogenase
Muscle damage marker
Time frame: 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
Time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Vertical jump
Muscle performance, vertical jump height
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Serum C-reactive protein
Inflammation measurement
Time frame: 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
Time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Plan to share: No — Depends on the journal where the paper will be published.
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Feb 2020, 23 months.
Of 877 non-industry interventional studies with no phase under Inflammation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 23 months is above that.
Counting every sponsor, half of 924 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Whey Proteins
Appalachian State University