The Effects of Whey Protein Supplements on Markers of Exercise-induced Muscle Damage in Resistance-trained Individuals (WheyProtein)

February 28, 2023 updated by: Tim Mickleborough, Indiana University

The Effects of Pasture-raised Versus Conventional Whey Protein Supplementation on Vascular Function and Markers of Exercise-induced Muscle Damage and Inflammation in Resistance-trained Individuals

Intense exercise can bring about various side effects to one's body. Less range of motion, increased pain sensitivity, increased muscle swelling, and decreased muscle strength can occur immediately after exercise. These side effects can be referred to exercise induced muscle damage (EIMD) and can sometimes last many days. This study's goal is to evaluate the effects of various protein supplements on EIMD symptoms as well as on blood vessel health during the recovery period after muscle damaging exercise.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Eccentric exercise can result in exercise induced muscle damage (EIMD), which can cause an abundance of ultrastructural muscular disruption and pro-inflammatory and pro-oxidant activity in the body, leading to an impairment of muscular force production and range of motion, along with elevated pain sensitivity, increased swelling, and arterial stiffness. Pasture-raised dairy products, obtained from strictly grass-fed cows, have been shown to possess more anti-inflammatory-, antioxidant-, and antihypertensive-like biochemicals compared with conventional products (i.e., with a different nutrient composition from a diet rich in grains versus grasses). However, human research trials on these products, such as whey protein concentrate (WPC), are neglected. This study addresses this gap, with a double-blind, randomized, placebo-controlled trial that compares the effect of conventional WPC versus WPC supplementation reported to be derived from pasture-raised cows on vascular function and indirect markers of muscle damage and inflammation in response to eccentric EIMD in healthy, young, resistance-trained women and men. Thirty resistance-trained individuals will complete an intense EIMD bout consisting of eccentric barbell back squats and then will be assessed 24, 48, and 72 hours post-EIMD for muscle soreness, range of motion, maximal isometric voluntary contraction, peripheral fatigue via magnetic stimulation, countermovement jump, barbell back squat velocity, and vascular function (i.e., arterial stiffness via carotid femoral pulse wave velocity). Subjects will be grouped into a conventional WPC, pasture-raised WPC, and placebo supplementation group and consume their respective supplementation thrice daily immediately post-EIMD until the study's completion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Matthew J Barenie, M.S.
  • Phone Number: 2197766740
  • Email: matbaren@iu.edu

Study Locations

  • United States
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Indiana University School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women 18-40 years old
  • ≥3 months uninterrupted training of ≥3 days/week of resistance training
  • Self-reported to be healthy

Exclusion Criteria:

  • Not within defined age range
  • History of allergy to dairy products
  • History of experiencing pain while exercising in the lower extremities (i.e., hips/knees)
  • Current use of anti-inflammatory/anti-pain medication (i.e., nonsteroidal anti-inflammatory drugs (NSAIDs) such as Tylenol, Advil, or Aleve
  • Are pregnant or could possibly be pregnant by self-report
  • People who answer 'yes' to any of the pre-participation screening questions on the PAR-Q questionnaire.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pasture-raised whey protein
whey protein from strictly grass fed cows
Dietary supplement: Pasture-raised whey protein
25 grams of protein delivered 3 times daily
Other Names:
  • Premium Blend Protein, Pasture Raised, Grass Fed, unflavored, Muscle Feast, Nashport, OH, USA
Experimental: Conventional whey protein
whey protein from conventional animal feeding operation
Dietary supplement: Conventional whey protein
25 grams of protein delivered 3 times daily
Other Names:
  • 100% Whey Protein Powder, unflavored, TGS Nutrition, Las Vegas, NV, USA
Placebo Comparator: Placebo
Maltodextrin given in iso-caloric amounts to protein
Dietary supplement: Placebo
Iso-caloric placebo taken 3 times daily like the protein supplementation
Other Names:
  • Maltodextrin, Bulk Supplements, Henderson, NV, USA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Titin
Time Frame: Four days
Muscle damage assessment via urinary titin via ELISA (MBS2881644, Human Titin ELISA® Kit, MyBioSource.com, Inc., San Diego, USA). Units: pmol
Four days
Isometric torque
Time Frame: Four days
Isometric torque assessment of right leg extensors will be conducted at a knee angle of 90 degrees using a calibrated load cell (model Z Tension Load Cell; Dillon, Fairmont, MN) Units: Nm
Four days
Range of motion
Time Frame: Four days
Hamstring flexibility and stiffness will be measured using a sit-and-reach box (Lafayette Instrument Company, Lafayette, IN) test. Units: cm
Four days
delayed onset muscle soreness
Time Frame: Four days
Visual analog scale of muscle soreness (delayed onset muscle soreness; DOMS) - Knee extensor soreness will be assessed using a visual analogue scale with "no soreness" indicated at one end (score 0) and "unbearably painful" at the other (score 100). Units: arbitrary units
Four days
Pain pressure threshold
Time Frame: Four days
Muscle tenderness, known as pain pressure threshold, will be quantified using a digital algometer (Force One, Wagner Instruments, Greenwich, CT) on pre-marked sites at two specific points on the quadriceps (rectus femoris-RF and vastus lateralis-VL) and one on the calf (gastrocnemius-GM). Units: percentage change from baseline
Four days
Peripheral Fatigue
Time Frame: Four days
Peripheral fatigue will be assessed via magnetic stimulation (Magstim 200-2; Jali Medical, Newton, MA, USA) of the femoral nerve, which will be used to elicit a quadriceps twitch. Units: Nm
Four days
Countermovement Jump
Time Frame: Four days
A linear position transducer (GymAware Powertool; Kinetic Performance Technology, Canberra, Australia) interfaced with an iPad (Apple, CA, USA) will be used to calculate countermovement jump (CMJ) height. Units: cm
Four days
Barbell back squat velocity
Time Frame: Four days
The mean velocity of the barbell will be measured using the linear position transducer as per the load velocity profile relationship. Units: m/s
Four days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Arterial Stiffness
Time Frame: Four days
Utilizing carotid femoral pulse wave velocity via applanation tonometry, considered the non-invasive gold standard of central arterial stiffness, the ATCOR SphygmoCor® (Naperville, IL, USA) device will be utilized. Units: m/sec
Four days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Timothy D Mickleborough, Ph.D., Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 14, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12559

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

Data obtained through this study may be provided to qualified researchers with academic interest in muscle damage. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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