Muscle DamageNCT04679519
The Effects of Protein Supplementation in Females and Males Following Acute Eccentric Exercise
A study testing Drop Jumps in people with Muscle Damage, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
Examine the impact of the protein supplements leucine, HMB and BCAA on muscle recovery and inflammatory response following acute exercise. 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?
- Drop Jumps
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2017to 25 Mar 2019
- 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
- Health recreationally active males and females.
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool John Moores University
Liverpool, Merseyside, L3 3AF
About this study
Examine the impact of the protein supplements leucine, HMB and BCAA on muscle recovery and inflammatory response following acute exercise.
Read the detailed description
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.
- Conditions
- Muscle Damage
- Being tested
- Drop Jumps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drop JumpsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Control group that was not given a supplement. Receives: Other: Drop Jumps |
| BCAA | Experimental | Supplement group that was given Branched Chain Amino Acids (BCAA). Receives: Other: Drop Jumps |
| Leucine | Experimental | Supplement group that was given Leucine. Receives: Other: Drop Jumps |
| HMB | Experimental | Supplement group that was given β-Hydroxy β-methylbutyric acid (HMB) Receives: Other: Drop Jumps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Creatine Kinase at baseline
Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.
Measured: Baseline
Concentration of Creatine Kinase immediately after intervention.
Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.
Measured: Immediately after intervention.
Concentration of Creatine Kinase at 24 hours after intervention.
Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.
Measured: 24 hours after intervention.
Concentration of Creatine Kinase at 48 hours after intervention.
Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.
Measured: 48 hours after intervention.
Concentration of Creatine Kinase at 7 days after intervention.
Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.
Measured: 7 days after intervention.
Concentration of Creatine Kinase at 14 days after intervention.
Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.
Measured: 14 days after intervention.
Number of Chair Rises at baseline
Stand and sit on chair consecutively for 30 seconds with hands placed on hips.
Measured: Baseline
Number of Chair Rises immediately after intervention.
Stand and sit on chair consecutively for 30 seconds with hands placed on hips.
Measured: Immediately after intervention.
Number of Chair Rises at 24 hours after intervention.
Stand and sit on chair consecutively for 30 seconds with hands placed on hips.
Measured: 24 hours after intervention.
Number of Chair Rises at 48 hours after intervention.
Stand and sit on chair consecutively for 30 seconds with hands placed on hips.
Measured: 48 hours after intervention.
Number of Chair Rises at 7 days after intervention.
Stand and sit on chair consecutively for 30 seconds with hands placed on hips.
Measured: 7 days after intervention.
Number of Chair Rises at 14 days after intervention.
Stand and sit on chair consecutively for 30 seconds with hands placed on hips.
Measured: 14 days after intervention.
Squat Jump height at baseline
Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally.
Measured: Baseline
Squat Jump height immediately after intervention.
Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally.
Measured: Immediately after intervention.
Squat Jump height at 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.
Measured: 24 hours after intervention.
Squat Jump height at 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.
Measured: 48 hours after intervention.
Squat Jump height at 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.
Measured: 7 days after intervention.
Squat Jump height at 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.
Measured: 14 days after intervention.
Range of motion at baseline.
Sit on chair, then flex and extend legs three times from 90 degrees position.
Measured: Baseline
Range of motion immediately after intervention.
Sit on chair, then flex and extend legs three times from 90 degrees position.
Measured: Immediately after intervention.
Range of motion at 24 hours after intervention.
Sit on chair, then flex and extend legs three times from 90 degrees position.
Measured: 24 hours after intervention.
Range of motion at 48 hours after intervention.
Sit on chair, then flex and extend legs three times from 90 degrees position.
Measured: 48 hours after intervention.
Range of motion at 7 days after intervention.
Sit on chair, then flex and extend legs three times from 90 degrees position.
Measured: 7 days after intervention.
Range of motion at 14 days after intervention.
Sit on chair, then flex and extend legs three times from 90 degrees position.
Measured: 14 days after intervention.
Inflammatory cytokines concentration at 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.
Measured: Baseline
Inflammatory cytokines concentration at 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.
Measured: 24 hours after intervention.
Inflammatory cytokines concentration at 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.
Measured: 48 hours after intervention.
Inflammatory cytokines concentration at 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.
Measured: 7 days after intervention.
Concentration of Lactate from baseline to immediately after intervention.
Blood drop from finger will be used to lactate.
Measured: Baseline and immediately after intervention.
Muscle Soreness
Record soreness on visual analogue scale from 1-10 1 = low soreness, 10 = extreme soreness.
Measured: Daily for 14 days.
Secondary outcomes (1)
Weighed food diaries.
Fill out dietary intake on food diary, by weighing food.
Measured: Daily for 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start6 Mar 2017
- Primary completion25 Mar 2019
- Study completion25 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised control study with four groups, one control and three protein supplements.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679519
- Sponsor's protocol ID
- 16/SPS/007
- Status last verified
- Dec 2020
- First submitted
- 10 Dec 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data to be published.
Publications
Howatson G, Hoad M, Goodall S, Tallent J, Bell PG, French DN. Exercise-induced muscle damage is reduced in resistance-trained males by branched chain amino acids: a randomized, double-blind, placebo controlled study. J Int Soc Sports Nutr. 2012 Jul 12;9:20. doi: 10.1186/1550-2783-9-20. eCollection 2012.
PubMed 22569039Kirby TJ, Triplett NT, Haines TL, Skinner JW, Fairbrother KR, McBride JM. Effect of leucine supplementation on indices of muscle damage following drop jumps and resistance exercise. Amino Acids. 2012 May;42(5):1987-96. doi: 10.1007/s00726-011-0928-9. Epub 2011 May 12.
PubMed 21562819
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Protein Supplementation in Females and Males Following Acute Eccentric Exercise
- ClinicalTrials.gov ID
- NCT04679519
- Acronym / sponsor ID
- 16/SPS/007
- Conditions
- Muscle Damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Examine the impact of the protein supplements leucine, HMB and BCAA on muscle recovery and inflammatory response following acute exercise.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Randomised control study with four groups, one control and three protein supplements.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Drop JumpsControl group that was not given a supplement. |
| BCAA | Experimental | Other: Drop JumpsSupplement group that was given Branched Chain Amino Acids (BCAA). |
| Leucine | Experimental | Other: Drop JumpsSupplement group that was given Leucine. |
| HMB | Experimental | Other: Drop JumpsSupplement group that was given β-Hydroxy β-methylbutyric acid (HMB) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Health recreationally active males and females.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drop JumpsPerform 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. | Other | BCAA, Control, HMB, Leucine |
Primary outcome
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.
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.
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.
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.
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.
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.
Number of Chair Rises at baseline
Time frame: Baseline
Stand and sit on chair consecutively for 30 seconds with hands placed on hips.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Range of motion at baseline.
Time frame: Baseline
Sit on chair, then flex and extend legs three times from 90 degrees position.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Muscle Soreness
Time frame: Daily for 14 days.
Record soreness on visual analogue scale from 1-10 1 = low soreness, 10 = extreme soreness.
1 secondary outcome
Weighed food diaries.
Time frame: Daily for 14 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Background: PubMed 22569039Howatson G, Hoad M, Goodall S, Tallent J, Bell PG, French DN. Exercise-induced muscle damage is reduced in resistance-trained males by branched chain amino acids: a randomized, double-blind, placebo controlled study. J Int Soc Sports Nutr. 2012 Jul 12;9:20. doi: 10.1186/1550-2783-9-20. eCollection 2012.
- Background: PubMed 21562819Kirby TJ, Triplett NT, Haines TL, Skinner JW, Fairbrother KR, McBride JM. Effect of leucine supplementation on indices of muscle damage following drop jumps and resistance exercise. Amino Acids. 2012 May;42(5):1987-96. doi: 10.1007/s00726-011-0928-9. Epub 2011 May 12.
- Individual participant dataSharing planned: Yes. Participant data to be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drop Jumps in people with Muscle Damage, run by Liverpool John Moores 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 1 inclusion and 22 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: finished, as of the sponsor's last update on 6 Jan 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Creatine Kinase at baseline (time frame: Baseline). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04679519, which also lists 2 linked publications.
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 6 Jan 2021.