The effect of combined β-lactoglobulin supplementation and resistance exercise training prior to limb immobilisation on muscle protein synthesis rates in healthy young adults: study protocol for a randomised controlled trial

Abstract Background The decline in skeletal muscle mass experienced following a short-term period (days to weeks) of muscle disuse is mediated by impaired rates of muscle protein synthesis (MPS). Previous RCTs of exercise or nutrition prehabilitation interventions designed to mitigate disuse-induced...

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Main Authors: Alix Hughes, Thomas Francis, Lindsey Marjoram, Jessica H. Rooney, Georgina Ellison-Hughes, Ross Pollock, Michael J. Curtis, Angela Cape, Mads Larsen, Bethan E. Phillips, Philip J. Atherton, Kenneth Smith, Oliver C. Witard
Format: Article
Language:English
Published: BMC 2023-06-01
Series:Trials
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Online Access:https://doi.org/10.1186/s13063-023-07329-6
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author Alix Hughes
Thomas Francis
Lindsey Marjoram
Jessica H. Rooney
Georgina Ellison-Hughes
Ross Pollock
Michael J. Curtis
Angela Cape
Mads Larsen
Bethan E. Phillips
Philip J. Atherton
Kenneth Smith
Oliver C. Witard
author_facet Alix Hughes
Thomas Francis
Lindsey Marjoram
Jessica H. Rooney
Georgina Ellison-Hughes
Ross Pollock
Michael J. Curtis
Angela Cape
Mads Larsen
Bethan E. Phillips
Philip J. Atherton
Kenneth Smith
Oliver C. Witard
author_sort Alix Hughes
collection DOAJ
description Abstract Background The decline in skeletal muscle mass experienced following a short-term period (days to weeks) of muscle disuse is mediated by impaired rates of muscle protein synthesis (MPS). Previous RCTs of exercise or nutrition prehabilitation interventions designed to mitigate disuse-induced muscle atrophy have reported limited efficacy. Hence, the aim of this study is to investigate the impact of a complex prehabilitation intervention that combines β-lactoglobulin (a novel milk protein with a high leucine content) supplementation with resistance exercise training on disuse-induced changes in free-living integrated rates of MPS in healthy, young adults. Methods/design To address this aim, we will recruit 24 healthy young (18–45 years) males and females to conduct a parallel, double-blind, 2-arm, randomised placebo-controlled trial. The intervention group will combine a 7-day structured resistance exercise training programme with thrice daily dietary supplementation with 23 g of β-lactoglobulin. The placebo group will combine the same training programme with an energy-matched carbohydrate (dextrose) control. The study protocol will last 16 days for each participant. Day 1 will be a familiarisation session and days 2–4 will be the baseline period. Days 5–11 represent the ‘prehabilitation period’ whereby participants will combine resistance training with their assigned dietary supplementation regimen. Days 12–16 represent the muscle disuse-induced ‘immobilisation period’ whereby participants will have a single leg immobilised in a brace and continue their assigned dietary supplementation regimen only (i.e. no resistance training). The primary endpoint of this study is the measurement of free-living integrated rates of MPS using deuterium oxide tracer methodology. Measurements of MPS will be calculated at baseline, over the 7-day prehabilitation period and over the 5-day immobilisation period separately. Secondary endpoints include measurements of muscle mass and strength that will be collected on days 4 (baseline), 11 (end of prehabilitation) and 16 (end of immobilisation). Discussion This novel study will establish the impact of a bimodal prehabilitation strategy that combines ß-lactoglobulin supplementation and resistance exercise training in modulating MPS following a short-term period of muscle disuse. If successful, this complex intervention may be translated to clinical practice with application to patients scheduled to undergo, for example, hip or knee replacement surgery. Trial registration NCT05496452. Registered on August 10, 2022. Protocol version: 16-12-2022/1
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spelling doaj.art-e7f89e2eaef94f89b8b81c7c4f1b35ea2023-06-18T11:24:10ZengBMCTrials1745-62152023-06-0124111110.1186/s13063-023-07329-6The effect of combined β-lactoglobulin supplementation and resistance exercise training prior to limb immobilisation on muscle protein synthesis rates in healthy young adults: study protocol for a randomised controlled trialAlix Hughes0Thomas Francis1Lindsey Marjoram2Jessica H. Rooney3Georgina Ellison-Hughes4Ross Pollock5Michael J. Curtis6Angela Cape7Mads Larsen8Bethan E. Phillips9Philip J. Atherton10Kenneth Smith11Oliver C. Witard12Centre for Human and Applied Physiological Sciences, King’s College LondonCentre for Human and Applied Physiological Sciences, King’s College LondonCentre for Human and Applied Physiological Sciences, King’s College LondonCentre for Human and Applied Physiological Sciences, King’s College LondonCentre for Human and Applied Physiological Sciences, King’s College LondonCentre for Human and Applied Physiological Sciences, King’s College LondonSchool of Cardiovascular Medicine & Sciences, King’s College LondonClinical Trials Unit, King’s College LondonArla Foods IngredientsSchool of Medicine, University of NottinghamSchool of Medicine, University of NottinghamSchool of Medicine, University of NottinghamCentre for Human and Applied Physiological Sciences, King’s College LondonAbstract Background The decline in skeletal muscle mass experienced following a short-term period (days to weeks) of muscle disuse is mediated by impaired rates of muscle protein synthesis (MPS). Previous RCTs of exercise or nutrition prehabilitation interventions designed to mitigate disuse-induced muscle atrophy have reported limited efficacy. Hence, the aim of this study is to investigate the impact of a complex prehabilitation intervention that combines β-lactoglobulin (a novel milk protein with a high leucine content) supplementation with resistance exercise training on disuse-induced changes in free-living integrated rates of MPS in healthy, young adults. Methods/design To address this aim, we will recruit 24 healthy young (18–45 years) males and females to conduct a parallel, double-blind, 2-arm, randomised placebo-controlled trial. The intervention group will combine a 7-day structured resistance exercise training programme with thrice daily dietary supplementation with 23 g of β-lactoglobulin. The placebo group will combine the same training programme with an energy-matched carbohydrate (dextrose) control. The study protocol will last 16 days for each participant. Day 1 will be a familiarisation session and days 2–4 will be the baseline period. Days 5–11 represent the ‘prehabilitation period’ whereby participants will combine resistance training with their assigned dietary supplementation regimen. Days 12–16 represent the muscle disuse-induced ‘immobilisation period’ whereby participants will have a single leg immobilised in a brace and continue their assigned dietary supplementation regimen only (i.e. no resistance training). The primary endpoint of this study is the measurement of free-living integrated rates of MPS using deuterium oxide tracer methodology. Measurements of MPS will be calculated at baseline, over the 7-day prehabilitation period and over the 5-day immobilisation period separately. Secondary endpoints include measurements of muscle mass and strength that will be collected on days 4 (baseline), 11 (end of prehabilitation) and 16 (end of immobilisation). Discussion This novel study will establish the impact of a bimodal prehabilitation strategy that combines ß-lactoglobulin supplementation and resistance exercise training in modulating MPS following a short-term period of muscle disuse. If successful, this complex intervention may be translated to clinical practice with application to patients scheduled to undergo, for example, hip or knee replacement surgery. Trial registration NCT05496452. Registered on August 10, 2022. Protocol version: 16-12-2022/1https://doi.org/10.1186/s13063-023-07329-6PrehabilitationMilk proteinMyofibrillar protein synthesisMuscle massMuscle disuse
spellingShingle Alix Hughes
Thomas Francis
Lindsey Marjoram
Jessica H. Rooney
Georgina Ellison-Hughes
Ross Pollock
Michael J. Curtis
Angela Cape
Mads Larsen
Bethan E. Phillips
Philip J. Atherton
Kenneth Smith
Oliver C. Witard
The effect of combined β-lactoglobulin supplementation and resistance exercise training prior to limb immobilisation on muscle protein synthesis rates in healthy young adults: study protocol for a randomised controlled trial
Trials
Prehabilitation
Milk protein
Myofibrillar protein synthesis
Muscle mass
Muscle disuse
title The effect of combined β-lactoglobulin supplementation and resistance exercise training prior to limb immobilisation on muscle protein synthesis rates in healthy young adults: study protocol for a randomised controlled trial
title_full The effect of combined β-lactoglobulin supplementation and resistance exercise training prior to limb immobilisation on muscle protein synthesis rates in healthy young adults: study protocol for a randomised controlled trial
title_fullStr The effect of combined β-lactoglobulin supplementation and resistance exercise training prior to limb immobilisation on muscle protein synthesis rates in healthy young adults: study protocol for a randomised controlled trial
title_full_unstemmed The effect of combined β-lactoglobulin supplementation and resistance exercise training prior to limb immobilisation on muscle protein synthesis rates in healthy young adults: study protocol for a randomised controlled trial
title_short The effect of combined β-lactoglobulin supplementation and resistance exercise training prior to limb immobilisation on muscle protein synthesis rates in healthy young adults: study protocol for a randomised controlled trial
title_sort effect of combined β lactoglobulin supplementation and resistance exercise training prior to limb immobilisation on muscle protein synthesis rates in healthy young adults study protocol for a randomised controlled trial
topic Prehabilitation
Milk protein
Myofibrillar protein synthesis
Muscle mass
Muscle disuse
url https://doi.org/10.1186/s13063-023-07329-6
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