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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United Kingdom
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control
Control group that was not given a supplement.
Other: Drop Jumps
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).
Other: Drop Jumps
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.
Other: Drop Jumps
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)
Other: Drop Jumps
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Record soreness on visual analogue scale from 1-10 1 = low soreness, 10 = extreme soreness.
Daily for 14 days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liverpool John Moores University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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