Clinical trial NCT03448328: Pea Protein Supplementation and Muscle Damage
Official title: Influence of Pea Protein Supplementation on Recovery From Exercise-induced Muscle Damage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Injury
Keywords: muscular strength
inflammation
protein
Lead sponsor: Appalachian State University
Sponsor class: OTHER
Collaborators: name: Roquette Freres
First posted: 2018-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel group
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum Creatine kinase
timeFrame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Secondary outcomes:
measure: Serum Myoglobin
timeFrame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
measure: Serum Lactate Dehydrogenase
timeFrame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
measure: Delayed onset of muscle soreness
timeFrame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
measure: Vertical jump
timeFrame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
measure: Bench press
timeFrame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
measure: Leg-back strength
timeFrame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
measure: 30-second Wingate cycle test
timeFrame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
measure: Serum C-reactive protein
timeFrame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
measure: Plasma cytokine panel
timeFrame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: Appalachian State University Human Performance Lab, North Carolina Research Campus
state: North Carolina
Study officials:
affiliation: Appalachian State Univ
name: David C Nieman, DrPH
role: PRINCIPAL_INVESTIGATOR
References: