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CompletedNCT03448328Updated Jul 15, 2020

Pea Protein Supplementation and Muscle Damage

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

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Muscular Injury

Keywords

  • muscular strength
  • inflammation
  • protein
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Pea Protein

    NUTRALYS pea protein supplement

    Dietary Supplement: NUTRALYS pea protein supplement

  • Experimental
    Whey Protein

    Whey protein supplement

    Dietary Supplement: Whey Protein

  • Active comparator
    Apple juice

    Apple juice

    Dietary Supplement: Apple juice

Interventions

  • Dietary supplementNUTRALYS 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

  • Dietary supplementWhey Protein

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

  • Dietary supplementApple juice

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

05

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. Serum Myoglobin

    Muscle damage marker

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

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

06

Study locations

1 site
  • Appalachian State University Human Performance Lab, North Carolina Research Campus
    Kannapolis, North Carolina 28081, United States
07

References and documents

Individual participant data

Plan to share: No — Depends on the journal where the paper will be published.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03448328
Lead sponsor
Appalachian State University
Collaborators
Roquette Freres
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Mar 5, 2018
Primary completion
Feb 15, 2020
Completion
Jun 1, 2020
Last update
Jul 15, 2020

Study contacts

David C Nieman, DrPH
principal investigator · Appalachian State Univ

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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