- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04679519
The Effects of Protein Supplementation in Females and Males Following Acute Eccentric Exercise
January 4, 2021 updated by: Liverpool John Moores University
Examine the impact of the protein supplements leucine, HMB and BCAA on muscle recovery and inflammatory response following acute exercise.
Study Overview
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 Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merseyside
-
Liverpool, Merseyside, United Kingdom, L3 3AF
- Liverpool John Moores University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
Control group that was not given a supplement.
|
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.
|
|
Experimental: BCAA
Supplement group that was given Branched Chain Amino Acids (BCAA).
|
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.
|
|
Experimental: Leucine
Supplement group that was given Leucine.
|
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.
|
|
Experimental: HMB
Supplement group that was given β-Hydroxy β-methylbutyric acid (HMB)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
|
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.
|
Immediately after intervention.
|
|
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.
|
24 hours after intervention.
|
|
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.
|
48 hours after intervention.
|
|
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.
|
7 days after intervention.
|
|
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.
|
14 days after intervention.
|
|
Number of Chair Rises at baseline
Time Frame: Baseline
|
Stand and sit on chair consecutively for 30 seconds with hands placed on hips.
|
Baseline
|
|
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.
|
Immediately after intervention.
|
|
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.
|
24 hours after intervention.
|
|
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.
|
48 hours after intervention.
|
|
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.
|
7 days after intervention.
|
|
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.
|
14 days after intervention.
|
|
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.
|
Baseline
|
|
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.
|
Immediately after intervention.
|
|
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.
|
24 hours after intervention.
|
|
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.
|
48 hours after intervention.
|
|
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.
|
7 days after intervention.
|
|
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.
|
14 days after intervention.
|
|
Range of motion at baseline.
Time Frame: Baseline
|
Sit on chair, then flex and extend legs three times from 90 degrees position.
|
Baseline
|
|
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.
|
Immediately after intervention.
|
|
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.
|
24 hours after intervention.
|
|
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.
|
48 hours after intervention.
|
|
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.
|
7 days after intervention.
|
|
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.
|
14 days after intervention.
|
|
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.
|
Baseline
|
|
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.
|
24 hours after intervention.
|
|
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.
|
48 hours after intervention.
|
|
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.
|
7 days after intervention.
|
|
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.
|
Baseline and immediately after intervention.
|
|
Muscle Soreness
Time Frame: Daily for 14 days.
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Record soreness on visual analogue scale from 1-10 1 = low soreness, 10 = extreme soreness.
|
Daily for 14 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weighed food diaries.
Time Frame: Daily for 14 days.
|
Fill out dietary intake on food diary, by weighing food.
|
Daily for 14 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Kirby 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2017
Primary Completion (Actual)
March 25, 2019
Study Completion (Actual)
March 25, 2019
Study Registration Dates
First Submitted
December 10, 2020
First Submitted That Met QC Criteria
December 16, 2020
First Posted (Actual)
December 22, 2020
Study Record Updates
Last Update Posted (Actual)
January 6, 2021
Last Update Submitted That Met QC Criteria
January 4, 2021
Last Verified
December 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 16/SPS/007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Participant data to be published.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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