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Completed

NCT Number: NCT03448328

Pea Protein Supplementation and Muscle Damage

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NUTRALYS pea protein supplement

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

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

Dietary Supplement

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Serum Myoglobin

    Time frame: Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after)

    Muscle damage marker

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Appalachian State University

Other

Collaborators

  • Roquette Freres

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2018
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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