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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05100459
Other study ID # 12559
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2021
Est. completion date June 14, 2022

Study information

Verified date February 2023
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date June 14, 2022
Est. primary completion date June 14, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Pasture-raised whey protein
25 grams of protein delivered 3 times daily
Conventional whey protein
25 grams of protein delivered 3 times daily
Placebo
Iso-caloric placebo taken 3 times daily like the protein supplementation

Locations

Country Name City State
United States Indiana University School of Public Health Bloomington Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Titin Muscle damage assessment via urinary titin via ELISA (MBS2881644, Human Titin ELISA® Kit, MyBioSource.com, Inc., San Diego, USA). Units: pmol Four days
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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 Four days
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