- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05100459
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
Completed
Conditions
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
Interventional
Enrollment (Actual)
39
Phase
- 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 Locations
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Pasture-raised whey protein
whey protein from strictly grass fed cows
|
25 grams of protein delivered 3 times daily
Other Names:
|
|
Experimental: Conventional whey protein
whey protein from conventional animal feeding operation
|
25 grams of protein delivered 3 times daily
Other Names:
|
|
Placebo Comparator: Placebo
Maltodextrin given in iso-caloric amounts to protein
|
Iso-caloric placebo taken 3 times daily like the protein supplementation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
November 15, 2021
Primary Completion (Actual)
June 14, 2022
Study Completion (Actual)
June 14, 2022
Study Registration Dates
First Submitted
October 19, 2021
First Submitted That Met QC Criteria
October 19, 2021
First Posted (Actual)
October 29, 2021
Study Record Updates
Last Update Posted (Actual)
March 2, 2023
Last Update Submitted That Met QC Criteria
February 28, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Muscle Soreness
-
Gazi UniversityCompletedDelayed Onset Muscle Soreness (DOMS)Turkey (Türkiye)
-
Applied Science & Performance InstituteNot yet recruitingMuscle Damage | Physical Performance | Muscle Recovery | Perceived Recovery | Strength Recovery | Perceived Muscle SorenessUnited States
-
Ebru Aloğlu ÇiftçiThe Scientific and Technological Research Council of TurkeyCompletedHealthy | Delayed Onset Muscle Soreness (DOMS)Turkey (Türkiye)
-
University of MinnesotaRecruitingExercise Induced Muscle Damage | Delayed Onset Muscle Soreness (DOMS)United States
-
University of Sistan and BaluchestanCompletedAthletic Injuries | Muscle Recovery | Exercise-induced Muscle Damage | Delayed-Onset Muscle Soreness (DOMS)Iran
-
Kaohsiung Medical University Chung-Ho Memorial...CompletedDelayed-onset Muscle SorenessTaiwan
-
NewChapter, Inc.Procter and GambleCompletedDelayed Onset Muscle SorenessUnited States
-
Lotus Clinical Research, LLCNovartis PharmaceuticalsCompletedPain | Delayed Onset Muscle SorenessUnited States
-
Prof. Dr. med. Frank Christoph MoorenUniversity of Giessen; Biologische Heilmittel Heel GmbHCompletedExercise-induced Muscle SorenessGermany
-
Canopy Growth CorporationCompletedDelayed Onset Muscle Soreness (DOMS)United States
Clinical Trials on Pasture-raised whey protein
-
University of Auckland, New ZealandSingapore Institute for Clinical Sciences; Massey University; AgResearch; The Riddet...CompletedDiet, Healthy | Protein; DiseaseNew Zealand
-
The University of Texas Medical Branch, GalvestonMeiji Co., Ltd.Completed
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); University of California, Davis and other collaboratorsCompletedRegulation of Muscle Protein SynthesisCanada
-
Sports Performance and Applied Research in Trials...RecruitingRecovery | Muscle Strength | Sports Nutritional Sciences | Supplements | Muscle Strength RecoveryUnited Kingdom
-
Efforia, IncActive, not recruiting
-
Musclegen Research, Inc.CompletedAbsorption; Disorder, Protein | Analysis, Event History
-
University of NottinghamCompletedAssessing the Impact of "Super-whey" vs. Isonitrogenous Whey on Muscle Protein Synthesis (ARLA-WHEY)SarcopeniaUnited Kingdom
-
University of ReginaIovate Health Sciences International IncRecruiting
-
Skidmore CollegeCompletedObesity | OverweightUnited States
-
Wenshan City People's HospitalNot yet recruitingIschemic Stroke | Traumatic Brain Injury | Neurocritical Conditions