Sex Differences in Muscle Damage Following Resistance Exercise With or Without Milk Protein Ingestion

NCT04986150 | Unknown

• 1 other identifier: 290580A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle Damage

Keywords

Exercise-induced muscle damage; Resistance exercise; Sex differences; Muscle soreness; Milk protein; Dietary protein

Outcome Measures

Primary Outcomes (39)

• Maximal Voluntary Contraction at baseline

  One-repetition maximum (1RM) test: leg extension and leg curl machines

  Baseline

• Change from baseline Maximal Voluntary Contraction at 72-hours post-exercise

  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

  One-repetition maximum (1RM) test: leg extension and leg curl machines

  168-hours after the exercise bout

• Creatine kinase concentration at baseline

  Serum concentration of creatine kinase from venous blood sampling

  Immediately pre-exercise

• Change from baseline in Creatine Kinase concentration immediately post-exercise

  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

  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

  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

  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

  Serum concentration of creatine kinase from venous blood sampling

  168-hours after the exercise bout

• Interleukin-6 concentration at baseline

  Serum concentration of Interleukin-6 from venous blood sampling

  Immediately pre-exercise

• Change from baseline in Interleukin-6 concentration immediately post-exercise

  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

  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

  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

  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

  Serum concentration of Interleukin-6 from venous blood sampling

  168-hours after the exercise bout

• Muscle soreness (pressure algometry) at baseline

  Self-perceived rating of muscle soreness with use of pressure algometry

  Immediately pre-exercise

• Change in muscle soreness (pressure algometry) immediately post-exercise

  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

  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

  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

  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

  Self-perceived rating of muscle soreness with use of pressure algometry

  168-hours after the exercise bout

• Muscle soreness (VAS) at baseline

  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

  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

  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

  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

  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

  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

  Flexibility of the exercised limb as determined by goniometry

  Immediately pre-exercise

• Change in range of motion immediately post-exercise

  Flexibility of the exercised limb as determined by goniometry

  Immediately after the exercise bout

• Change in range of motion at 24-hours post-exercise

  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

  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

  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

  Flexibility of the exercised limb as determined by goniometry

  168-hours after the exercise bout

• Limb circumference at baseline

  Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling

  Immediately pre-exercise

• Change in limb circumference immediately post-exercise

  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

  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

  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

  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

  Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling

  168-hours after the exercise bout

Study Arms (2)

Milk Protein

EXPERIMENTAL

4 daily 20-gram doses of milk protein (dairy yoghurt) consumed for 4 consecutive days after the exercise bout

Other: Resistance exercise

Placebo

PLACEBO COMPARATOR

4 daily doses of low-protein placebo product (oat-based yoghurt) consumed for 4 consecutive days after the exercise bout

Other: Resistance exercise

Interventions

Resistance exercise OTHER

Acute leg-based resistance exercise bout performed at 80% 1RM (4 sets to volitional failure on leg extension and leg curl machines)

Milk Protein; Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Durham University: lead

Study Sites (1)

Durham University, Sports and Wellbeing Park

Durham, DH1 3HN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Myalgia

Interventions

Resistance Training

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alice G Pearson

  Durham University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice G Pearson

CONTACT

07771357222; alice.g.pearson@durham.ac.uk

Lindsay S Macnaughton

CONTACT

lindsay.s.macnaughton@durham.ac.uk

Study Design

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

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: August 2, 2021
• Study Start: August 31, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: October 27, 2021

Record last verified: 2021-10

Locations

GB (1)