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CompletedNCT03297151Updated Jan 31, 2025

Protein Supplementation and Recovery of Muscle Function

An interventional study of CONTROL and Whey Protein Concentrate in Resistance Training and Muscle Damage, sponsored by University of Limerick. Completed at 1 site in Ireland. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-31.

Sponsored by University of Limerick · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Male
01

Study 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.

Read the detailed description

Study Design: A block randomised design of 3 groups of resistance-exercise trained (RET) men

Participants: 24 young, healthy, resistance exercise trained, males aged 18 - 35 years.

Recovery drinks; CONTROL - an isonitrogenous, non-essential amino acid solution; PROTEIN - a milk-based whey protein concentrate (WPC), WPC-80; HYDROLYSATE - a hydrolysed derivative of WPC-80.

Day 1, Pre-screening consisting of:

  • medical history and examination by a clinician
  • blood sample to be evaluated for health-related contraindications
  • body composition measurement by dual energy x-ray absorptiometry (DXA) to determine whole body and segmental lean tissue mass;
  • exercise training log (6 month recall);
  • dietary consultation;
  • habitual physical activity level assessed by European Physical Activity Questionaire (EPAQ)-2

Day 2 - 8: Participants will be "free-living" during this time. Participants will record dietary intake under the guidance of a qualified dietitian and sports nutritionist.

Day 9 and 10: Participants will complete two familiarisation sessions to the resistance exercise and muscle function testing procedures.

A single blood sample (5ml) will be drawn following o/n fast on each day. On day 2 participants will drink a metered dose of deuterated water (around 200ml) containing deuterium. A saliva sample will be taken before and after consuming this bolus.

Day 11-17. During this experimental phase diet is prescribed and provided. The diet is based on habitual food intake standardized to body mass.

Day 11: O/n fasted blood, saliva and 1st micro-biopsy of muscle obtained; Muscle function measured prior to and upon completion of a prescribed bout of resistance exercise training (RET); The recovery drink (0.33 g protein/kg body mass) is ingested; 3 hours following completion of RET a 2nd micro-biopsy of muscle is obtained.

Day 12: O/n fasted blood and saliva is obtained Muscle function measured and recovery drink (0.33 g protein/kg body mass) consumed.

Day 13: O/n fasted blood and saliva is obtained Muscle function measured followed by the 2nd RET bout and recovery drink (0.33 g protein/kg body mass) consumed.

Day 14: O/n fasted blood and saliva is obtained Muscle function measured and recovery drink (0.33 g protein/kg body mass) consumed.

Day 15: O/n fasted blood and saliva is obtained Muscle function measured followed by the 3rd RET bout and recovery drink (0.33 g protein/kg body mass) consumed.

Day 16 O/n fasted blood, saliva and 3rd micro-biopsy of muscle obtained Muscle function measured and recovery drink (0.33 g protein/kg body mass) consumed.

Day 17: O/n fasted blood and saliva is obtained Muscle function measured

02

Conditions studied

  • Resistance Training
  • Muscle Damage

Keywords

  • Resistance Training
  • Muscle Function
  • Protein Synthesis
03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • recent musculoskeletal injury
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Investigator)
Enrollment
22 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Dietary supplementCONTROL

    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

  • Dietary supplementWhey 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

    Also known as: Carbelac80 Instant

  • Dietary supplementWhey 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

05

What researchers measure

Primary outcomes

  1. Change in Muscle Contractile Function

    Maximal Voluntary Contract (MVC) of Knee Extensor Muscle measured by laboratory-based ergometry

    Time frame: Day 9, 10, 11, 12, 13, 14, 15, 16 and 17

Secondary outcomes

  1. Change in Muscle Protein Synthesis

    The fractional rate of muscle protein synthesis (MPS) measured by deuterium incorporation into skeletal muscle sampled by microbiopsy

    Time frame: Day 11 and 16

06

Study locations

1 site
  • University of Limerick
    Limerick, Co Limerick, Ireland
07

References and documents

Study documents

  • Study protocol · Dec 9, 2016
  • Statistical analysis plan · Dec 9, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03297151
Lead sponsor
University of Limerick
Responsible party
Sponsor
First posted
Sep 29, 2017
Start date
Jul 1, 2017
Primary completion
Sep 30, 2017
Completion
Mar 20, 2021
Last update
Jan 31, 2025

Study contacts

Philip M Jakeman, PhD
principal investigator · University of Limerick

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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