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Muscle DamageEIMD-MILKNCT04986150

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

A study testing Resistance exercise in people with Muscle Damage, run by Durham University at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 … Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Muscle Damage
What is being tested?
Resistance exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
31 Aug 2021to Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Lindsay S Macnaughton contact

lindsay.s.macnaughton@durham.ac.uk

United Kingdom1 site, 1 recruiting
  • Durham University, Sports and Wellbeing Park

    Durham, DH1 3HN

    Alice G Pearson, 07771357222, alice.g.pearson@durham.ac.uk

    Lindsay S Macnaughton, lindsay.s.macnaughton@durham.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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.

Read more

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
Being tested
Resistance exercise
Keywords
Exercise-induced muscle damage, Resistance exercise, Sex differences, Muscle soreness, Milk protein, Dietary protein
Medical subject headings
Myalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance exerciseOther

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

Study groups in NCT04986150
Study groupRoleWhat they receive
Milk ProteinExperimental4 daily 20-gram doses of milk protein (dairy yoghurt) consumed for 4 consecutive days after the exercise bout
Receives: Other: Resistance exercise
PlaceboPlacebo comparator4 daily doses of low-protein placebo product (oat-based yoghurt) consumed for 4 consecutive days after the exercise bout
Receives: Other: Resistance exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal Voluntary Contraction at baseline

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

    Measured: Baseline

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

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

    Measured: 72-hours after the exercise bout

  3. Change from baseline Maximal Voluntary Contraction at 168-hours post-exercise

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

    Measured: 168-hours after the exercise bout

  4. Creatine kinase concentration at baseline

    Serum concentration of creatine kinase from venous blood sampling

    Measured: Immediately pre-exercise

  5. Change from baseline in Creatine Kinase concentration immediately post-exercise

    Serum concentration of creatine kinase from venous blood sampling

    Measured: Immediately after the exercise bout

  6. Change from baseline in Creatine Kinase concentration at 24-hours post-exercise

    Serum concentration of creatine kinase from venous blood sampling

    Measured: 24-hours after the exercise bout

  7. Change from baseline in Creatine Kinase concentration at 48-hours post-exercise

    Serum concentration of creatine kinase from venous blood sampling

    Measured: 48-hours after the exercise bout

  8. Change from baseline in Creatine Kinase concentration at 72-hours post-exercise

    Serum concentration of creatine kinase from venous blood sampling

    Measured: 72-hours after the exercise bout

  9. Change from baseline in Creatine Kinase concentration at 168-hours post-exercise

    Serum concentration of creatine kinase from venous blood sampling

    Measured: 168-hours after the exercise bout

  10. Interleukin-6 concentration at baseline

    Serum concentration of Interleukin-6 from venous blood sampling

    Measured: Immediately pre-exercise

  11. Change from baseline in Interleukin-6 concentration immediately post-exercise

    Serum concentration of Interleukin-6 from venous blood sampling

    Measured: Immediately after the exercise bout

  12. Change from baseline in Interleukin-6 concentration at 24-hours post-exercise

    Serum concentration of Interleukin-6 from venous blood sampling

    Measured: 24-hours after the exercise bout

  13. Change from baseline in Interleukin-6 concentration at 48-hours post-exercise

    Serum concentration of Interleukin-6 from venous blood sampling

    Measured: 48-hours after the exercise bout

  14. Change from baseline in Interleukin-6 concentration at 72-hours post-exercise

    Serum concentration of Interleukin-6 from venous blood sampling

    Measured: 72-hours after the exercise bout

  15. Change from baseline in Interleukin-6 concentration at 168-hours post-exercise

    Serum concentration of Interleukin-6 from venous blood sampling

    Measured: 168-hours after the exercise bout

  16. Muscle soreness (pressure algometry) at baseline

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

    Measured: Immediately pre-exercise

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

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

    Measured: Immediately after the exercise bout

  18. Change in muscle soreness (pressure algometry) at 24-hours post-exercise

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

    Measured: 24-hours after the exercise bout

  19. Change in muscle soreness (pressure algometry) at 48-hours post-exercise

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

    Measured: 48-hours after the exercise bout

  20. Change in muscle soreness (pressure algometry) at 72-hours post-exercise

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

    Measured: 72-hours after the exercise bout

  21. Change in muscle soreness (pressure algometry) at 168-hours post-exercise

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

    Measured: 168-hours after the exercise bout

  22. Muscle soreness (VAS) at baseline

    Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale

    Measured: Immediately pre-exercise

  23. 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

    Measured: Immediately after the exercise bout

  24. 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

    Measured: 24-hours after the exercise bout

  25. 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

    Measured: 48-hours after the exercise bout

  26. 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

    Measured: 72-hours after the exercise bout

  27. 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

    Measured: 168-hours after the exercise bout

  28. Range of motion at baseline

    Flexibility of the exercised limb as determined by goniometry

    Measured: Immediately pre-exercise

  29. Change in range of motion immediately post-exercise

    Flexibility of the exercised limb as determined by goniometry

    Measured: Immediately after the exercise bout

  30. Change in range of motion at 24-hours post-exercise

    Flexibility of the exercised limb as determined by goniometry

    Measured: 24-hours after the exercise bout

  31. Change in range of motion at 48-hours post-exercise

    Flexibility of the exercised limb as determined by goniometry

    Measured: 48-hours after the exercise bout

  32. Change in range of motion at 72-hours post-exercise

    Flexibility of the exercised limb as determined by goniometry

    Measured: 72-hours after the exercise bout

  33. Change in range of motion at 168-hours post-exercise

    Flexibility of the exercised limb as determined by goniometry

    Measured: 168-hours after the exercise bout

  34. Limb circumference at baseline

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

    Measured: Immediately pre-exercise

  35. Change in limb circumference immediately post-exercise

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

    Measured: Immediately after the exercise bout

  36. Change in limb circumference at 24-hours post-exercise

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

    Measured: 24-hours after the exercise bout

  37. Change in limb circumference at 48-hours post-exercise

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

    Measured: 48-hours after the exercise bout

  38. Change in limb circumference at 72-hours post-exercise

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

    Measured: 72-hours after the exercise bout

  39. Change in limb circumference at 168-hours post-exercise

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

    Measured: 168-hours after the exercise bout

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2021
  2. Study start31 Aug 2021
  3. Primary completionSep 2022 (estimated)
  4. Study completionSep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04986150
Sponsor's protocol ID
290580A
Acronym
EIMD-MILK
Status last verified
Oct 2021
First submitted
30 Jun 2021
Last updated
27 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Resistance exercise in people with Muscle Damage, run by Durham University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alice G Pearson (07771357222, alice.g.pearson@durham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Voluntary Contraction at baseline (time frame: Baseline). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.

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