The Effects of Whey Protein Supplements on Markers of Exercise-induced Muscle Damage in Resistance-trained Individuals (WheyProtein)
Primary Purpose
Muscle Damage, Muscle Soreness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pasture-raised whey protein
Conventional whey protein
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Muscle Damage
Eligibility Criteria
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.
Sites / Locations
- Indiana University School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Pasture-raised whey protein
Conventional whey protein
Placebo
Arm Description
whey protein from strictly grass fed cows
whey protein from conventional animal feeding operation
Maltodextrin given in iso-caloric amounts to protein
Outcomes
Primary Outcome Measures
Titin
Muscle damage assessment via urinary titin via ELISA (MBS2881644, Human Titin ELISA® Kit, MyBioSource.com, Inc., San Diego, USA). Units: pmol
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
Range of motion
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
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
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
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
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
The mean velocity of the barbell will be measured using the linear position transducer as per the load velocity profile relationship. Units: m/s
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05100459
Brief Title
The Effects of Whey Protein Supplements on Markers of Exercise-induced Muscle Damage in Resistance-trained Individuals
Acronym
WheyProtein
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
June 14, 2022 (Actual)
Study Completion Date
June 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Damage, Muscle Soreness
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pasture-raised whey protein
Arm Type
Experimental
Arm Description
whey protein from strictly grass fed cows
Arm Title
Conventional whey protein
Arm Type
Experimental
Arm Description
whey protein from conventional animal feeding operation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin given in iso-caloric amounts to protein
Intervention Type
Dietary Supplement
Intervention Name(s)
Pasture-raised whey protein
Other Intervention Name(s)
Premium Blend Protein, Pasture Raised, Grass Fed, unflavored, Muscle Feast, Nashport, OH, USA
Intervention Description
25 grams of protein delivered 3 times daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Conventional whey protein
Other Intervention Name(s)
100% Whey Protein Powder, unflavored, TGS Nutrition, Las Vegas, NV, USA
Intervention Description
25 grams of protein delivered 3 times daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Maltodextrin, Bulk Supplements, Henderson, NV, USA
Intervention Description
Iso-caloric placebo taken 3 times daily like the protein supplementation
Primary Outcome Measure Information:
Title
Titin
Description
Muscle damage assessment via urinary titin via ELISA (MBS2881644, Human Titin ELISA® Kit, MyBioSource.com, Inc., San Diego, USA). Units: pmol
Time Frame
Four days
Title
Isometric torque
Description
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
Time Frame
Four days
Title
Range of motion
Description
Hamstring flexibility and stiffness will be measured using a sit-and-reach box (Lafayette Instrument Company, Lafayette, IN) test. Units: cm
Time Frame
Four days
Title
delayed onset muscle soreness
Description
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
Time Frame
Four days
Title
Pain pressure threshold
Description
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
Time Frame
Four days
Title
Peripheral Fatigue
Description
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
Time Frame
Four days
Title
Countermovement Jump
Description
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
Time Frame
Four days
Title
Barbell back squat velocity
Description
The mean velocity of the barbell will be measured using the linear position transducer as per the load velocity profile relationship. Units: m/s
Time Frame
Four days
Secondary Outcome Measure Information:
Title
Arterial Stiffness
Description
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
Time Frame
Four days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy D Mickleborough, Ph.D.
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Public Health
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
The Effects of Whey Protein Supplements on Markers of Exercise-induced Muscle Damage in Resistance-trained Individuals
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