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Completed

NCT Number: NCT04679519

The Effects of Protein Supplementation in Females and Males Following Acute Eccentric Exercise

Examine the impact of the protein supplements leucine, HMB and BCAA on muscle recovery and inflammatory response following acute exercise.

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Key information

Conditions

Muscle Damage

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool John Moores University

Liverpool, Merseyside, L3 3AF, United Kingdom

About this study

Participants, both females and males, will perform an acute bout of exercise. A bout of exercise that will involve multiple drop jumps. Prior to and post exercise, functional outputs will be measured and blood will be collected to quantify the inflammatory response. The protocol will involve attending the laboratory on 6 occasions over a two week period to complete the above measures.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Health recreationally active males and females.

Exclusion criteria

  • Asthma sufferers
  • People with kidney disease
  • People partaking in lower limb strength training
  • People suffering DOMS in the past 6 months
  • People already taking dietary supplements, other NSAIDs, or for example aspirin, alcohol, warfarin, phenytoin, methotrexate, lithium, diuretics, cyclosporine.
  • People with bone or soft tissue injury within last 12 months
  • People with gastric problems
  • People with hypertension
  • People who have had history of heart failure
  • People with liver disease
  • People with connective tissue disorders
  • People with Crohn's disease
  • People with ulcerative colitis
  • People with peripheral arterial disease
  • People with cerebrovascular disease
  • Elderly population
  • People with allergies to NSAIDs, Omega- 3 fatty acids and BCAAs.
  • People with depression
  • People with bipolar disorder
  • People with diabetes
  • Females who are pregnant
  • People who have HIV / AIDS

Treatment and study plan

Drop Jumps

Other

Perform 100 drop jumps from 40 cm height. The protocol is divided into 5 sets of 20 repetitions. Between each repetition participants get 10 seconds, and between each set 2 minutes rest. Stand on the box, drop of the box and land with feet shoulder width apart. Then immediately bend knee to approx 45 degrees and jump straight up. Throughout each jump hands are placed on hips and should not move.

Primary outcomes

  1. Concentration of Creatine Kinase at baseline

    Time frame: Baseline

    Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.

  2. Concentration of Creatine Kinase immediately after intervention.

    Time frame: Immediately after intervention.

    Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.

  3. Concentration of Creatine Kinase at 24 hours after intervention.

    Time frame: 24 hours after intervention.

    Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.

  4. Concentration of Creatine Kinase at 48 hours after intervention.

    Time frame: 48 hours after intervention.

    Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.

  5. Concentration of Creatine Kinase at 7 days after intervention.

    Time frame: 7 days after intervention.

    Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.

  6. Concentration of Creatine Kinase at 14 days after intervention.

    Time frame: 14 days after intervention.

    Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.

  7. Number of Chair Rises at baseline

    Time frame: Baseline

    Stand and sit on chair consecutively for 30 seconds with hands placed on hips.

  8. Number of Chair Rises immediately after intervention.

    Time frame: Immediately after intervention.

    Stand and sit on chair consecutively for 30 seconds with hands placed on hips.

  9. Number of Chair Rises at 24 hours after intervention.

    Time frame: 24 hours after intervention.

    Stand and sit on chair consecutively for 30 seconds with hands placed on hips.

  10. Number of Chair Rises at 48 hours after intervention.

    Time frame: 48 hours after intervention.

    Stand and sit on chair consecutively for 30 seconds with hands placed on hips.

  11. Number of Chair Rises at 7 days after intervention.

    Time frame: 7 days after intervention.

    Stand and sit on chair consecutively for 30 seconds with hands placed on hips.

  12. Number of Chair Rises at 14 days after intervention.

    Time frame: 14 days after intervention.

    Stand and sit on chair consecutively for 30 seconds with hands placed on hips.

  13. Squat Jump height at baseline

    Time frame: Baseline

    Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally.

  14. Squat Jump height immediately after intervention.

    Time frame: Immediately after intervention.

    Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally.

  15. Squat Jump height at 24 hours after intervention.

    Time frame: 24 hours after intervention.

    Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally.

  16. Squat Jump height at 48 hours after intervention.

    Time frame: 48 hours after intervention.

    Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally.

  17. Squat Jump height at 7 days after intervention.

    Time frame: 7 days after intervention.

    Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally.

  18. Squat Jump height at 14 days after intervention.

    Time frame: 14 days after intervention.

    Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally.

  19. Range of motion at baseline.

    Time frame: Baseline

    Sit on chair, then flex and extend legs three times from 90 degrees position.

  20. Range of motion immediately after intervention.

    Time frame: Immediately after intervention.

    Sit on chair, then flex and extend legs three times from 90 degrees position.

  21. Range of motion at 24 hours after intervention.

    Time frame: 24 hours after intervention.

    Sit on chair, then flex and extend legs three times from 90 degrees position.

  22. Range of motion at 48 hours after intervention.

    Time frame: 48 hours after intervention.

    Sit on chair, then flex and extend legs three times from 90 degrees position.

  23. Range of motion at 7 days after intervention.

    Time frame: 7 days after intervention.

    Sit on chair, then flex and extend legs three times from 90 degrees position.

  24. Range of motion at 14 days after intervention.

    Time frame: 14 days after intervention.

    Sit on chair, then flex and extend legs three times from 90 degrees position.

  25. Inflammatory cytokines concentration at baseline

    Time frame: Baseline

    Blood from vein will be analysed for 10 different cytokines. Different cytokines include interleukins 1 beta, 2, 3, 4, 7, 8, 10, 17 and tutor necrosis factor receptor 1.

  26. Inflammatory cytokines concentration at 24 hours after intervention.

    Time frame: 24 hours after intervention.

    Blood from vein will be analysed for 10 different cytokines. Different cytokines include interleukins 1 beta, 2, 3, 4, 7, 8, 10, 17 and tutor necrosis factor receptor 1.

  27. Inflammatory cytokines concentration at 48 hours after intervention.

    Time frame: 48 hours after intervention.

    Blood from vein will be analysed for 10 different cytokines. Different cytokines include interleukins 1 beta, 2, 3, 4, 7, 8, 10, 17 and tutor necrosis factor receptor 1.

  28. Inflammatory cytokines concentration at 7 days after intervention.

    Time frame: 7 days after intervention.

    Blood from vein will be analysed for 10 different cytokines. Different cytokines include interleukins 1 beta, 2, 3, 4, 7, 8, 10, 17 and tutor necrosis factor receptor 1.

  29. Concentration of Lactate from baseline to immediately after intervention.

    Time frame: Baseline and immediately after intervention.

    Blood drop from finger will be used to lactate.

  30. Muscle Soreness

    Time frame: Daily for 14 days.

    Record soreness on visual analogue scale from 1-10 1 = low soreness, 10 = extreme soreness.

Secondary outcomes

  1. Weighed food diaries.

    Time frame: Daily for 14 days.

    Fill out dietary intake on food diary, by weighing food.

Sponsors and collaborators

Lead sponsor

Liverpool John Moores University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 22, 2020
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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