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

NCT05100459 | Completed DMC

• 1 other identifier: 12559
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Damage; Muscle Soreness

Outcome Measures

Primary Outcomes (8)

• Titin

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (1)

• Arterial Stiffness

  Four days

Study Arms (3)

Pasture-raised whey protein

EXPERIMENTAL

whey protein from strictly grass fed cows

Dietary Supplement: Pasture-raised whey protein

Conventional whey protein

EXPERIMENTAL

whey protein from conventional animal feeding operation

Dietary Supplement: Conventional whey protein

Placebo

PLACEBO COMPARATOR

Maltodextrin given in iso-caloric amounts to protein

Dietary Supplement: Placebo

Interventions

Pasture-raised whey protein DIETARY_SUPPLEMENT

25 grams of protein delivered 3 times daily

Also known as: Premium Blend Protein, Pasture Raised, Grass Fed, unflavored, Muscle Feast, Nashport, OH, USA

Pasture-raised whey protein

Conventional whey protein DIETARY_SUPPLEMENT

25 grams of protein delivered 3 times daily

Also known as: 100% Whey Protein Powder, unflavored, TGS Nutrition, Las Vegas, NV, USA

Conventional whey protein

Placebo DIETARY_SUPPLEMENT

Iso-caloric placebo taken 3 times daily like the protein supplementation

Also known as: Maltodextrin, Bulk Supplements, Henderson, NV, USA

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Public Health

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Myalgia

Interventions

hydroxide ion; maltodextrin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Timothy D Mickleborough, Ph.D.

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: October 29, 2021
• Study Start: November 15, 2021
• Primary Completion: June 14, 2022
• Study Completion: June 14, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication
• 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.

Locations

US (1)