Pea Protein Supplementation and Muscle Damage

Muscular Injury Clinical Trial

Official title:

Influence of Pea Protein Supplementation on Recovery From Exercise-induced Muscle Damage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448328
• Other study ID #: 18-0165
• Status: Completed
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2020
• Source: Appalachian State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 muscle soreness (DOMS), and speed recovery of muscle function.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 1, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscular Injury

Intervention

Dietary Supplement:
• 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
• Whey Protein
0.3 grams of protein per kilogram of body weight before and after eccentric exercise, and each of 4 mornings of recovery
• Apple juice
1.2 calories per kilogram body weight before and after eccentric exercise, and each of 4 mornings of recovery

Locations

Country	Name	City	State
United States	Appalachian State University Human Performance Lab, North Carolina Research Campus	Kannapolis	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Appalachian State University	Roquette Freres

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Creatine kinase	Muscle damage marker	Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Secondary	Serum Myoglobin	Muscle damage marker	Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Secondary	Serum Lactate Dehydrogenase	Muscle damage marker	Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Secondary	Delayed onset of muscle soreness	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)
Secondary	Vertical jump	Muscle performance, vertical jump height	Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Secondary	Bench press	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)
Secondary	Leg-back strength	Muscle performance, leg-back strength with a dynamometer	Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Secondary	30-second Wingate cycle test	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)
Secondary	Serum C-reactive protein	Inflammation measurement	Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)
Secondary	Plasma cytokine panel	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)