Pea Protein Supplementation and Muscle Damage

NCT ID: NCT03448328

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-05
• Study Completion Date: 2020-06-01

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.

Conditions

Muscular Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pea Protein

NUTRALYS pea protein supplement

Group Type: EXPERIMENTAL

NUTRALYS pea protein supplement

Intervention Type: DIETARY_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

Whey protein supplement

Group Type: EXPERIMENTAL

Whey Protein

Intervention Type: DIETARY_SUPPLEMENT

0.3 grams of protein per kilogram of body weight before and after eccentric exercise, and each of 4 mornings of recovery

Apple juice

Apple juice

Group Type: ACTIVE_COMPARATOR

Apple juice

Intervention Type: DIETARY_SUPPLEMENT

1.2 calories per kilogram body weight before and after eccentric exercise, and each of 4 mornings of recovery

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Whey Protein

0.3 grams of protein per kilogram of body weight before and after eccentric exercise, and each of 4 mornings of recovery

Intervention Type: DIETARY_SUPPLEMENT

Apple juice

1.2 calories per kilogram body weight before and after eccentric exercise, and each of 4 mornings of recovery

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Roquette Freres

INDUSTRY

Sponsor Role: collaborator

Appalachian State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David C Nieman, DrPH

Role: PRINCIPAL_INVESTIGATOR

Appalachian State Univ

Locations

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, United States

Countries

United States

Other Identifiers

18-0165

Identifier Type: -

Identifier Source: org_study_id