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Protein Supplementation and Recovery of Muscle Function

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ClinicalTrials.gov Identifier: NCT03297151
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Phil Jakeman, University of Limerick

Brief Summary:

The focus is performance nutrition. Resistance exercise can induce low level muscle damage in conjunction with impaired contractile function. Milk-derived proteins contain, or induce, bioactive properties that assist muscle recovery and restore/improve muscle function. The aim of the research is the recovery of muscle function following resistance exercise.

In this study, the investigators propose to undertake a comparison of the ingestion of two milk-derived protein-based recovery drinks on muscle function after resistance exercise compares to an isonitrogenous, non-essential amino acid control.


Condition or disease Intervention/treatment Phase
Resistance Training Muscle Damage Dietary Supplement: CONTROL Dietary Supplement: Whey Protein Concentrate Dietary Supplement: Whey Protein Hydrolysate Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Block randomised, between group study
Masking: Double (Participant, Investigator)
Masking Description: Double blind (participant and investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Milk Derived Protein Supplementation on Muscle Recovery Following Resistance Exercise
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : September 30, 2017
Estimated Study Completion Date : December 30, 2017

Arm Intervention/treatment
Sham Comparator: CONTROL

Intervention: Dietary Supplement: Non-essential amino acids A group of subjects ingesting a liquid beverage (per kilogram body mass: 0.33g non-essential amino acids dissolved in water ) prior to completion of a prescribed resistance exercise training (RET) session.

Muscle Contractile Function to be conducted prior to and following the RET session by laboratory-based ergometry.

Muscle Protein Synthesis induced by RET to be measured by deuterium incorporation in to skeletal muscle sampled by microbiopsy.

Dietary Supplement: CONTROL

Food grade mixture of non-essential amino acids in powdered form, flavoured and instantised to be dissolved in water.

Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Product Reference Number 10955


Active Comparator: PROTEIN

Intervention: Dietary Supplement: Whey Protein Concentrate A group of subjects ingesting a liquid beverage (per kilogram body mass: 0.33g of Whey Protein Concentrate dissolved in water ) prior to completion of a prescribed resistance exercise training (RET) session.

Muscle Contractile Function to be conducted prior to and following the RET session by laboratory-based ergometry. Muscle Protein Synthesis induced by RET to be measured by deuterium incorporation in to skeletal muscle sampled by microbiopsy.

Dietary Supplement: Whey Protein Concentrate

Whey protein concentrate in powdered form, flavoured and instantised to be dissolved in water.

Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Trade name of product is Carbelac80 Instant Product Reference Number 10431

Other Name: Carbelac80 Instant

Active Comparator: HYDROLYSATE

Intervention: Dietary Supplement: Whey Protein Hydrolysate A group of subjects ingesting a liquid beverage (per kilogram body mass: 0.33g of Whey Protein Hydrolysate dissolved in water ) prior to completion of a prescribed resistance exercise training (RET) session.

Muscle Contractile Function to be conducted prior to and following the RET session by laboratory-based ergometry. Muscle Protein Synthesis induced by RET to be measured by deuterium incorporation in to skeletal muscle sampled by microbiopsy.

Dietary Supplement: Whey Protein Hydrolysate

Whey protein concentrate hydrolysate (degree of hydrolysate 27%) in powdered form, flavoured and instantised to be dissolved in water.

Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Product Reference Number 10468





Primary Outcome Measures :
  1. Change in Muscle Contractile Function [ Time Frame: Day 9, 10, 11, 12, 13, 14, 15, 16 and 17 ]
    Maximal Voluntary Contract (MVC) of Knee Extensor Muscle measured by laboratory-based ergometry


Secondary Outcome Measures :
  1. Change in Muscle Protein Synthesis [ Time Frame: Day 11 and 16 ]
    The fractional rate of muscle protein synthesis (MPS) measured by deuterium incorporation into skeletal muscle sampled by microbiopsy



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • risk
  • no known current illness or physically active
  • resistance-exercise trained
  • no known intolerance to milk-based products
  • no known blood born disease or medication that would adversely affect participation
  • no adverse risk to venepuncture

Exclusion Criteria:

• recent musculoskeletal injury


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297151


Contacts
Contact: Philip M Jakeman, PhD +35361202800 ext 2800 phil.jakeman@ul.ie
Contact: Mary Clarke-Moloney, BSc +35361204230 ext 4230 Mary.ClarkMoloney@ul.ie

Locations
Ireland
University of Limerick Recruiting
Limerick, Co Limerick, Ireland
Contact: Philip Jakeman, PhD    +35361202800    phil.jakeman@ul.ie   
Contact: Dick Fitzgerald, PhD    +35361202598    dick.fitzgerald@ul.ie   
Principal Investigator: Philip Jakeman, PhD         
Sub-Investigator: Dick Fitzgerald, PhD         
Sponsors and Collaborators
University of Limerick
Investigators
Principal Investigator: Philip M Jakeman, PhD University of Limerick
  Study Documents (Full-Text)

Documents provided by Phil Jakeman, University of Limerick:
Study Protocol  [PDF] December 9, 2016
Statistical Analysis Plan  [PDF] December 9, 2016


Additional Information:
Responsible Party: Phil Jakeman, Principal Investigator, University of Limerick
ClinicalTrials.gov Identifier: NCT03297151     History of Changes
Other Study ID Numbers: FHIHAPN3.3RX
TC20130001 ( Other Grant/Funding Number: Enterprise Ireland )
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Phil Jakeman, University of Limerick:
Resistance Training
Muscle Function
Protein Synthesis