- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04986150
Sex Differences in Muscle Damage Following Resistance Exercise With or Without Milk Protein Ingestion (EIMD-MILK)
Sex Differences in Resistance Exercise-induced Muscle Damage: The Impact of Milk Protein Ingestion
Purpose: To investigate the impact of milk protein ingestion on resistance exercise-induced muscle damage in untrained males and females.
Rationale: Unaccustomed resistance exercise can cause muscle damage, presenting as muscle soreness and reduced muscle function - such as loss of strength, power, and flexibility - for several days after the exercise bout. Therefore, individuals may require longer recovery periods before performing another exercise bout, and their performance may be impaired. Further, muscle soreness may reduce exercise compliance, particularly in novice individuals. Over time, this may compromise the gains in muscle mass and strength achieved through exercise training. Therefore, strategies to reduce the severity of exercise-induced muscle damage and/or to enhance post-exercise recovery processes are advantageous for exercising individuals.
One such strategy is the consumption of dietary protein before or after muscle-damaging exercise, which has shown to alleviate muscle soreness, improve blood markers of muscle damage, and reduce the decline in maximal force and flexibility. In particular, consuming 20-gram doses of milk protein in the days after resistance exercise can improve the recovery time of muscle soreness and maximum force, and also lower levels of damage markers in the blood. However, most studies have been conducted with male participants who are well-trained in resistance exercise. It has been suggested that males and females respond differently to muscle damage, and therefore, this research aims to provide a sex comparison in the muscle damage response to an acute bout of resistance exercise with or without milk protein feeding.
Therefore, 40 healthy, young (18-35 years) adults (20 males, 20 females) will be recruited to participate in this randomised controlled trial. Maximal leg strength and body composition (by dual-energy X-ray absorptiometry; DXA) will be conducted at baseline. In females, all primary outcome measures will be obtained during the late follicular phase of the menstrual cycle. Participants will then be randomised to a protein (dairy yoghurt) or placebo (oat-based yoghurt) dietary condition.
Three weeks later, participants will complete a high-intensity resistance exercise session on leg extension and leg curl machines to induce muscle damage. Various measures of muscle damage (blood biomarkers, muscle soreness, flexibility, and swelling) will be obtained before, immediately after, and 24, 48, 72, and 168 h after the exercise protocol. The maximal strength test will be repeated 72 and 168 h after the exercise. Participants will consume the protein or placebo yoghurt 4 times per day (every 3-4 hours) on the day of the exercise bout and the following 3 days. Participants' habitual activity and dietary intake will be monitored and controlled throughout the study period.
Expected outcome: It is expected that the resistance exercise protocol will induce muscle damage, which will be attenuated with the ingestion of milk protein. It cannot be ascertained whether males and females will have the same responses to the exercise or to protein ingestion.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alice G Pearson
- Phone Number: 07771357222
- Email: alice.g.pearson@durham.ac.uk
Study Contact Backup
- Name: Lindsay S Macnaughton
- Email: lindsay.s.macnaughton@durham.ac.uk
Study Locations
-
-
-
Durham, United Kingdom, DH1 3HN
- Recruiting
- Durham University, Sports and Wellbeing Park
-
Contact:
- Alice G Pearson
- Phone Number: 07771357222
- Email: alice.g.pearson@durham.ac.uk
-
Contact:
- Lindsay S Macnaughton
- Email: lindsay.s.macnaughton@durham.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI 18.5 - 25.0 kg/m2
- Untrained in resistance exercise
- No known chronic disease or current acute illness
- No current or recent (past 3 months) musculoskeletal injury
- No frequent use (2x per week for past month) of non-steroidal anti-inflammatory drugs and compliant to abstain from use during experimental period
- No recent or current engagement in massage or cryotherapy and compliant to abstain from use during experimental period
- No current use of protein or antioxidant supplements
- Are able to consume dairy products (i.e., not lactose-intolerant or vegan)
- Females will be eumenorrheic (regular menstrual cycle) >12 months
- Absence of pregnancy and breast-feeding
Exclusion Criteria:
- Underweight
- Overweight/obese
- Resistance trained
- Current or recent injury
- Pregnancy or breast-feeding
- Lactose intolerant
- Unwilling to provide blood samples, perform resistance exercise, or abstain from use of NSAID's and protein supplementation (unless instructed as part of the research)
- Unwilling to abstain from other forms of exercise during the experimental period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Milk Protein
4 daily 20-gram doses of milk protein (dairy yoghurt) consumed for 4 consecutive days after the exercise bout
|
Acute leg-based resistance exercise bout performed at 80% 1RM (4 sets to volitional failure on leg extension and leg curl machines)
|
PLACEBO_COMPARATOR: Placebo
4 daily doses of low-protein placebo product (oat-based yoghurt) consumed for 4 consecutive days after the exercise bout
|
Acute leg-based resistance exercise bout performed at 80% 1RM (4 sets to volitional failure on leg extension and leg curl machines)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal Voluntary Contraction at baseline
Time Frame: Baseline
|
One-repetition maximum (1RM) test: leg extension and leg curl machines
|
Baseline
|
Change from baseline Maximal Voluntary Contraction at 72-hours post-exercise
Time Frame: 72-hours after the exercise bout
|
One-repetition maximum (1RM) test: leg extension and leg curl machines
|
72-hours after the exercise bout
|
Change from baseline Maximal Voluntary Contraction at 168-hours post-exercise
Time Frame: 168-hours after the exercise bout
|
One-repetition maximum (1RM) test: leg extension and leg curl machines
|
168-hours after the exercise bout
|
Creatine kinase concentration at baseline
Time Frame: Immediately pre-exercise
|
Serum concentration of creatine kinase from venous blood sampling
|
Immediately pre-exercise
|
Change from baseline in Creatine Kinase concentration immediately post-exercise
Time Frame: Immediately after the exercise bout
|
Serum concentration of creatine kinase from venous blood sampling
|
Immediately after the exercise bout
|
Change from baseline in Creatine Kinase concentration at 24-hours post-exercise
Time Frame: 24-hours after the exercise bout
|
Serum concentration of creatine kinase from venous blood sampling
|
24-hours after the exercise bout
|
Change from baseline in Creatine Kinase concentration at 48-hours post-exercise
Time Frame: 48-hours after the exercise bout
|
Serum concentration of creatine kinase from venous blood sampling
|
48-hours after the exercise bout
|
Change from baseline in Creatine Kinase concentration at 72-hours post-exercise
Time Frame: 72-hours after the exercise bout
|
Serum concentration of creatine kinase from venous blood sampling
|
72-hours after the exercise bout
|
Change from baseline in Creatine Kinase concentration at 168-hours post-exercise
Time Frame: 168-hours after the exercise bout
|
Serum concentration of creatine kinase from venous blood sampling
|
168-hours after the exercise bout
|
Interleukin-6 concentration at baseline
Time Frame: Immediately pre-exercise
|
Serum concentration of Interleukin-6 from venous blood sampling
|
Immediately pre-exercise
|
Change from baseline in Interleukin-6 concentration immediately post-exercise
Time Frame: Immediately after the exercise bout
|
Serum concentration of Interleukin-6 from venous blood sampling
|
Immediately after the exercise bout
|
Change from baseline in Interleukin-6 concentration at 24-hours post-exercise
Time Frame: 24-hours after the exercise bout
|
Serum concentration of Interleukin-6 from venous blood sampling
|
24-hours after the exercise bout
|
Change from baseline in Interleukin-6 concentration at 48-hours post-exercise
Time Frame: 48-hours after the exercise bout
|
Serum concentration of Interleukin-6 from venous blood sampling
|
48-hours after the exercise bout
|
Change from baseline in Interleukin-6 concentration at 72-hours post-exercise
Time Frame: 72-hours after the exercise bout
|
Serum concentration of Interleukin-6 from venous blood sampling
|
72-hours after the exercise bout
|
Change from baseline in Interleukin-6 concentration at 168-hours post-exercise
Time Frame: 168-hours after the exercise bout
|
Serum concentration of Interleukin-6 from venous blood sampling
|
168-hours after the exercise bout
|
Muscle soreness (pressure algometry) at baseline
Time Frame: Immediately pre-exercise
|
Self-perceived rating of muscle soreness with use of pressure algometry
|
Immediately pre-exercise
|
Change in muscle soreness (pressure algometry) immediately post-exercise
Time Frame: Immediately after the exercise bout
|
Self-perceived rating of muscle soreness with use of pressure algometry
|
Immediately after the exercise bout
|
Change in muscle soreness (pressure algometry) at 24-hours post-exercise
Time Frame: 24-hours after the exercise bout
|
Self-perceived rating of muscle soreness with use of pressure algometry
|
24-hours after the exercise bout
|
Change in muscle soreness (pressure algometry) at 48-hours post-exercise
Time Frame: 48-hours after the exercise bout
|
Self-perceived rating of muscle soreness with use of pressure algometry
|
48-hours after the exercise bout
|
Change in muscle soreness (pressure algometry) at 72-hours post-exercise
Time Frame: 72-hours after the exercise bout
|
Self-perceived rating of muscle soreness with use of pressure algometry
|
72-hours after the exercise bout
|
Change in muscle soreness (pressure algometry) at 168-hours post-exercise
Time Frame: 168-hours after the exercise bout
|
Self-perceived rating of muscle soreness with use of pressure algometry
|
168-hours after the exercise bout
|
Muscle soreness (VAS) at baseline
Time Frame: Immediately pre-exercise
|
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
|
Immediately pre-exercise
|
Change in muscle soreness (VAS) immediately post-exercise
Time Frame: Immediately after the exercise bout
|
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
|
Immediately after the exercise bout
|
Change in muscle soreness (VAS) at 24-hours post-exercise
Time Frame: 24-hours after the exercise bout
|
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
|
24-hours after the exercise bout
|
Change in muscle soreness (VAS) at 48-hours post-exercise
Time Frame: 48-hours after the exercise bout
|
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
|
48-hours after the exercise bout
|
Change in muscle soreness (VAS) at 72-hours post-exercise
Time Frame: 72-hours after the exercise bout
|
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
|
72-hours after the exercise bout
|
Change in muscle soreness (VAS) at 168-hours post-exercise
Time Frame: 168-hours after the exercise bout
|
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
|
168-hours after the exercise bout
|
Range of motion at baseline
Time Frame: Immediately pre-exercise
|
Flexibility of the exercised limb as determined by goniometry
|
Immediately pre-exercise
|
Change in range of motion immediately post-exercise
Time Frame: Immediately after the exercise bout
|
Flexibility of the exercised limb as determined by goniometry
|
Immediately after the exercise bout
|
Change in range of motion at 24-hours post-exercise
Time Frame: 24-hours after the exercise bout
|
Flexibility of the exercised limb as determined by goniometry
|
24-hours after the exercise bout
|
Change in range of motion at 48-hours post-exercise
Time Frame: 48-hours after the exercise bout
|
Flexibility of the exercised limb as determined by goniometry
|
48-hours after the exercise bout
|
Change in range of motion at 72-hours post-exercise
Time Frame: 72-hours after the exercise bout
|
Flexibility of the exercised limb as determined by goniometry
|
72-hours after the exercise bout
|
Change in range of motion at 168-hours post-exercise
Time Frame: 168-hours after the exercise bout
|
Flexibility of the exercised limb as determined by goniometry
|
168-hours after the exercise bout
|
Limb circumference at baseline
Time Frame: Immediately pre-exercise
|
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
|
Immediately pre-exercise
|
Change in limb circumference immediately post-exercise
Time Frame: Immediately after the exercise bout
|
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
|
Immediately after the exercise bout
|
Change in limb circumference at 24-hours post-exercise
Time Frame: 24-hours after the exercise bout
|
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
|
24-hours after the exercise bout
|
Change in limb circumference at 48-hours post-exercise
Time Frame: 48-hours after the exercise bout
|
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
|
48-hours after the exercise bout
|
Change in limb circumference at 72-hours post-exercise
Time Frame: 72-hours after the exercise bout
|
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
|
72-hours after the exercise bout
|
Change in limb circumference at 168-hours post-exercise
Time Frame: 168-hours after the exercise bout
|
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
|
168-hours after the exercise bout
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 290580A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Damage
-
University of ThessalyCompletedAthletic Performance | Muscle Damage | Skeletal Muscle DamageGreece
-
University of New MexicoWithdrawn
-
University of SurreyCompletedMuscle DamageUnited Kingdom
-
Federal University of Health Science of Porto AlegreCompleted
-
Federal University of Health Science of Porto AlegreCompleted
-
University of ThessalyCompleted
-
Durham UniversitySuspendedMuscle DamageUnited Kingdom
-
Western University, CanadaUnknown
-
St Mary's University CollegeCompleted
Clinical Trials on Resistance exercise
-
Princess Nourah Bint Abdulrahman UniversityKırıkkale UniversityCompleted
-
Universidade Federal de PernambucoUnknownChikungunya FeverBrazil
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)TerminatedChildhood ObesityUnited States
-
Instituto de Cardiologia do Rio Grande do SulCompletedHypertension | Healthy
-
Iowa State UniversityCompletedCardiovascular Risk Factor
-
University of AlbertaDexCom, Inc.CompletedType 1 DiabetesCanada
-
Mekelle UniversityCompleted
-
VA Office of Research and DevelopmentRecruiting
-
University of AlbertaCompletedType 1 DiabetesCanada
-
University of BirminghamMaastricht UniversityRecruitingSarcopenia | Resistance Exercise | Dietary ProteinUnited Kingdom