NCT03448328

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

February 22, 2018

Last Update Submit

July 14, 2020

Conditions

Keywords

muscular strengthinflammationprotein

Outcome Measures

Primary Outcomes (1)

  • Serum Creatine kinase

    Muscle damage marker

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

Secondary Outcomes (9)

  • Serum Myoglobin

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

  • Serum Lactate Dehydrogenase

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

  • Delayed onset of muscle soreness

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

  • Vertical jump

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

  • Bench press

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

  • +4 more secondary outcomes

Study Arms (3)

Pea Protein

EXPERIMENTAL

NUTRALYS pea protein supplement

Dietary Supplement: NUTRALYS pea protein supplement

Whey Protein

EXPERIMENTAL

Whey protein supplement

Dietary Supplement: Whey Protein

Apple juice

ACTIVE COMPARATOR

Apple juice

Dietary Supplement: Apple juice

Interventions

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

Pea Protein
Whey ProteinDIETARY_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
Apple juiceDIETARY_SUPPLEMENT

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

Apple juice

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • David C Nieman, DrPH

    Appalachian State Univ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized, parallel group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2018

First Posted

February 28, 2018

Study Start

March 5, 2018

Primary Completion

February 15, 2020

Study Completion

June 1, 2020

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Depends on the journal where the paper will be published.

Locations