Muscle DamageWheyProteinNCT05100459
The Effects of Whey Protein Supplements on Markers of Exercise-induced Muscle Damage in Resistance-trained Individuals
A study testing Pasture-raised whey protein and Conventional whey protein in people with Muscle Damage and Muscle Soreness, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage, Muscle Soreness
- What is being tested?
- Pasture-raised whey protein and Conventional whey protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 14 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women 18-40 years old
- ≥3 months uninterrupted training of ≥3 days/week of resistance training
- Self-reported to be healthy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Public Health
Bloomington, Indiana, 47405
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Damage, Muscle Soreness
- Being tested
- Pasture-raised whey protein, Conventional whey protein, Placebo
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasture-raised whey proteinDietary supplement
Also called Premium Blend Protein, Pasture Raised, Grass Fed, unflavored, Muscle Feast, Nashport, OH, USA
25 grams of protein delivered 3 times daily
Conventional whey proteinDietary supplement
Also called 100% Whey Protein Powder, unflavored, TGS Nutrition, Las Vegas, NV, USA
25 grams of protein delivered 3 times daily
PlaceboDietary supplement
Also called Maltodextrin, Bulk Supplements, Henderson, NV, USA
Iso-caloric placebo taken 3 times daily like the protein supplementation
| Study group | Role | What they receive |
|---|---|---|
| Pasture-raised whey protein | Experimental | whey protein from strictly grass fed cows Receives: Dietary Supplement: Pasture-raised whey protein |
| Conventional whey protein | Experimental | whey protein from conventional animal feeding operation Receives: Dietary Supplement: Conventional whey protein |
| Placebo | Placebo comparator | Maltodextrin given in iso-caloric amounts to protein Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titin
Muscle damage assessment via urinary titin via ELISA (MBS2881644, Human Titin ELISA® Kit, MyBioSource.com, Inc., San Diego, USA). Units: pmol
Measured: Four days
Isometric torque
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
Measured: Four days
Range of motion
Hamstring flexibility and stiffness will be measured using a sit-and-reach box (Lafayette Instrument Company, Lafayette, IN) test. Units: cm
Measured: Four days
delayed onset muscle soreness
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
Measured: Four days
Pain pressure threshold
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
Measured: Four days
Peripheral Fatigue
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
Measured: Four days
Countermovement Jump
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
Measured: Four days
Barbell back squat velocity
The mean velocity of the barbell will be measured using the linear position transducer as per the load velocity profile relationship. Units: m/s
Measured: Four days
Secondary outcomes (1)
Arterial Stiffness
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
Measured: Four days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start15 Nov 2021
- Primary completion14 Jun 2022
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Mickleborough, Indiana University
- Investigators
- Timothy D Mickleborough, Ph.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100459
- Sponsor's protocol ID
- 12559
- Acronym
- WheyProtein
- Status last verified
- Feb 2023
- First submitted
- 19 Oct 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05100459
- Acronym / sponsor ID
- WheyProtein / 12559
- Conditions
- Muscle Damage, Muscle Soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pasture-raised whey protein | Experimental | Dietary Supplement: Pasture-raised whey proteinwhey protein from strictly grass fed cows |
| Conventional whey protein | Experimental | Dietary Supplement: Conventional whey proteinwhey protein from conventional animal feeding operation |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin given in iso-caloric amounts to protein |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men and women 18-40 years old
- ≥3 months uninterrupted training of ≥3 days/week of resistance training
- Self-reported to be healthy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pasture-raised whey proteinAlso: Premium Blend Protein, Pasture Raised, Grass Fed, unflavored, Muscle Feast, Nashport, OH, USA25 grams of protein delivered 3 times daily | Dietary supplement | Pasture-raised whey protein |
| Conventional whey proteinAlso: 100% Whey Protein Powder, unflavored, TGS Nutrition, Las Vegas, NV, USA25 grams of protein delivered 3 times daily | Dietary supplement | Conventional whey protein |
| PlaceboAlso: Maltodextrin, Bulk Supplements, Henderson, NV, USAIso-caloric placebo taken 3 times daily like the protein supplementation | Dietary supplement | Placebo |
Primary outcome
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
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
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
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
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
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
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
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
1 secondary outcome
Arterial Stiffness
Time frame: Four days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy D Mickleborough, Ph.D. principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pasture-raised whey protein and Conventional whey protein in people with Muscle Damage and Muscle Soreness, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Titin (time frame: Four days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.