Resistance TrainingNCT03297151
Protein Supplementation and Recovery of Muscle Function
A study testing Whey Protein Concentrate and Whey Protein Hydrolysate in people with Resistance Training and Muscle Damage, run by University of Limerick at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Resistance Training, Muscle Damage
- What is being tested?
- Whey Protein Concentrate and Whey Protein Hydrolysate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jul 2017to 20 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- recent musculoskeletal injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Milk Derived Protein Supplementation on Muscle Recovery Following Resistance Exercise
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
- Conditions
- Resistance Training, Muscle Damage
- Being tested
- CONTROL, Whey Protein Concentrate, Whey Protein Hydrolysate
- Keywords
- Resistance Training, Muscle Function, Protein Synthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONTROLDietary supplement
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
Whey Protein ConcentrateDietary supplement
Also called Carbelac80 Instant
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
Whey Protein HydrolysateDietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Sham comparator | 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. Receives: Dietary Supplement: CONTROL |
| PROTEIN | Active comparator | 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. Receives: Dietary Supplement: Whey Protein Concentrate |
| HYDROLYSATE | Active comparator | 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. Receives: Dietary Supplement: Whey Protein Hydrolysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle Contractile Function
Maximal Voluntary Contract (MVC) of Knee Extensor Muscle measured by laboratory-based ergometry
Measured: 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
Measured: Day 11 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 Jul 2017
- Primary completion30 Sep 2017
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Block randomised, between group study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip M Jakeman, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297151
- Sponsor's protocol ID
- FHIHAPN3.3RX
- Other IDs
- TC20130001
- Status last verified
- Jan 2025
- First submitted
- 17 Aug 2017
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Milk Derived Protein Supplementation on Muscle Recovery Following Resistance Exercise
- ClinicalTrials.gov ID
- NCT03297151
- Acronym / sponsor ID
- FHIHAPN3.3RX
- Conditions
- Resistance Training, Muscle Damage
- Keywords
- Resistance Training, Muscle Function, Protein Synthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Block randomised, between group study
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Sham comparator | Dietary Supplement: CONTROLIntervention: 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. |
| PROTEIN | Active comparator | Dietary Supplement: Whey Protein ConcentrateIntervention: 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. |
| HYDROLYSATE | Active comparator | Dietary Supplement: Whey Protein HydrolysateIntervention: 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- recent musculoskeletal injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONTROLFood 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 supplement | CONTROL |
| Whey Protein ConcentrateAlso: Carbelac80 InstantWhey 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 | Dietary supplement | PROTEIN |
| Whey Protein HydrolysateWhey 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 | Dietary supplement | HYDROLYSATE |
Primary outcome
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
1 secondary outcome
Change in Muscle Protein Synthesis
Time frame: Day 11 and 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Food For Health Ireland National Technology CentreLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip M Jakeman, PhD principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein Concentrate and Whey Protein Hydrolysate in people with Resistance Training and Muscle Damage, run by University of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle Contractile Function (time frame: Day 9, 10, 11, 12, 13, 14, 15, 16 and 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.