Protein-energy; ImbalanceNCT05998603
Pre-sleep Protein Supplementation and Load Carriage Recovery in British Army Recruits
A study testing High protein intake and Moderate protein intake in people with Protein-energy; Imbalance and Muscle Soreness, run by Anglia Ruskin University at 1 site in United Kingdom.
Trial summary
Load carriage is a common military activity and has been shown to induce acute exercise-induced muscle damage (EIMD) and impair muscle function. Protein supplementation can accelerate muscle recovery by attenuating EIMD and muscle function loss. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein-energy; Imbalance, Muscle Soreness
- What is being tested?
- High protein intake and Moderate protein intake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2021to 31 May 2022
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Enrolled into British Army basic training
- Medically fit to train and complete the load carriage test
Who cannot join
- Not taking any other nutritional supplement
- Pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Anglia Ruskin University
Cambridge, Cambridgeshire, CB1 1PT
About this study
Official title: Pre-sleep Protein Supplementation Does Not Improve Recovery From Load Carriage in British Army Recruits
Load carriage is a common military activity and has been shown to induce acute exercise-induced muscle damage (EIMD) and impair muscle function. Protein supplementation can accelerate muscle recovery by attenuating EIMD and muscle function loss. This study investigated the impact of an additional daily bolus of protein prior to sleep throughout training on acute muscle recovery following a load carriage test in British Army recruits. Muscle function (maximal jump height), perceived muscle soreness and urinary markers of muscle damage were assessed before (PRE), immediately post (POST), 24-hours post (24h-POST) and 40-hours post (40h-POST) a load carriage test.
Read the detailed description
British Army basic training (BT) is physically demanding with new recruits completing multiple bouts of physical activity each day with limited recovery. Load carriage is one of the most physically demanding BT activities and has been shown to induce acute exercise-induced muscle damage (EIMD) and impair muscle function. Protein supplementation can accelerate muscle recovery by attenuating EIMD and muscle function loss. This study investigated the impact of an additional daily bolus of protein prior to sleep throughout training on acute muscle recovery following a load carriage test in United Kingdom (UK) British Army recruits. A mixed group (men/women) over over 120 new recruits were randomised to dietary control (CON), carbohydrate placebo (PLA), moderate (20g; MOD) or high (60g; HIGH) protein supplementation. Muscle function (maximal jump height), perceived muscle soreness and urinary markers of muscle damage were assessed before (PRE), immediately post (POST), 24-hours post (24h-POST) and 40-hours post (40h-POST) a load carriage test. The underlying aim of this study was to assess whether additional protein intake could attenuate aspects of muscle damage from an acute load carriage test including muscle function, muscle soreness and biomarkers of muscle damage during short term recovery.
- Conditions
- Protein-energy; Imbalance, Muscle Soreness
- Being tested
- High protein intake, Moderate protein intake, Carbohydrate maltodextrin placebo, Control no supplementation
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein intakeDietary supplement
The participants received a 60g whey protein bolus each evening prior to sleep pre and post a military load carriage test.
Moderate protein intakeDietary supplement
The participants received a 20g whey protein bolus each evening prior to sleep pre and post a military load carriage test.
Carbohydrate maltodextrin placeboDietary supplement
The participants received an isocaloric carbohydrate bolus each evening prior to sleep pre and post a military load carriage test.
Control no supplementationOther
Control group, no supplementation, only basic training
| Study group | Role | What they receive |
|---|---|---|
| High protein intake supplementation | Experimental | A 60g daily dose of whey protein supplementation Receives: Dietary Supplement: High protein intake |
| Moderate protein intake supplementation | Experimental | A 20g dose of whey protein supplementation Receives: Dietary Supplement: Moderate protein intake |
| Carbohydrate placebo | Placebo comparator | An isocaloic maltodextrin carbohydrate placebo Receives: Dietary Supplement: Carbohydrate maltodextrin placebo |
| Control group, no supplementation | Other | Control group, not taking any supplementation, only completing basic training activities Receives: Other: Control no supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lower body muscle function
The change in maximal vertical jump height in participants before and after the load carriage test
Measured: 40-hours
Secondary outcomes (3)
The change in urinary myoglobin
The relative change in concentration of urinary myoglobin (ng/ml) in participants before and after the load carriage test
Measured: 40-hours
The change in urinary 3-methylhistidine
The relative change in concentration of urinary 3-methylhistidine (nmol/ml) in participants before and after the load carriage test
Measured: 40-hours
The change in perceived muscle soreness
The relative change in perceived muscle soreness assessed via visual analogue scale. The participants were asked to record their perceived muscle soreness using a 0-10 Likert scale (e.g., 0=no pain, 10=severe pain that limits the ability to move).
Measured: 40-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 May 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein-energy; ImbalanceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anglia Ruskin University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter
- Responsible party
- Sponsor
- Investigators
- Justin D Roberts, PhD, Principal investigator, Anglia Ruskin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998603
- Sponsor's protocol ID
- 1076/MODREC/20B
- Status last verified
- Feb 2024
- First submitted
- 3 Aug 2023
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-sleep Protein Supplementation Does Not Improve Recovery From Load Carriage in British Army Recruits
- ClinicalTrials.gov ID
- NCT05998603
- Acronym / sponsor ID
- 1076/MODREC/20B
- Conditions
- Protein-energy; Imbalance, Muscle Soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Anglia Ruskin UniversityUniversity, hospital or other
- Collaborators
- University of Exeter
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 21 Aug 2023 (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.
Load carriage is a common military activity and has been shown to induce acute exercise-induced muscle damage (EIMD) and impair muscle function. Protein supplementation can accelerate muscle recovery by attenuating EIMD and muscle function loss. This study investigated the impact of an additional daily bolus of protein prior to sleep throughout training on acute muscle recovery following a load carriage test in British Army recruits. Muscle function (maximal jump height), perceived muscle soreness and urinary markers of muscle damage were assessed before (PRE), immediately post (POST), 24-hours post (24h-POST) and 40-hours post (40h-POST) a load carriage test.
Detailed description
British Army basic training (BT) is physically demanding with new recruits completing multiple bouts of physical activity each day with limited recovery. Load carriage is one of the most physically demanding BT activities and has been shown to induce acute exercise-induced muscle damage (EIMD) and impair muscle function. Protein supplementation can accelerate muscle recovery by attenuating EIMD and muscle function loss. This study investigated the impact of an additional daily bolus of protein prior to sleep throughout training on acute muscle recovery following a load carriage test in United Kingdom (UK) British Army recruits. A mixed group (men/women) over over 120 new recruits were randomised to dietary control (CON), carbohydrate placebo (PLA), moderate (20g; MOD) or high (60g; HIGH) protein supplementation. Muscle function (maximal jump height), perceived muscle soreness and urinary markers of muscle damage were assessed before (PRE), immediately post (POST), 24-hours post (24h-POST) and 40-hours post (40h-POST) a load carriage test. The underlying aim of this study was to assess whether additional protein intake could attenuate aspects of muscle damage from an acute load carriage test including muscle function, muscle soreness and biomarkers of muscle damage during short term recovery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High protein intake supplementation | Experimental | Dietary Supplement: High protein intakeA 60g daily dose of whey protein supplementation |
| Moderate protein intake supplementation | Experimental | Dietary Supplement: Moderate protein intakeA 20g dose of whey protein supplementation |
| Carbohydrate placebo | Placebo comparator | Dietary Supplement: Carbohydrate maltodextrin placeboAn isocaloic maltodextrin carbohydrate placebo |
| Control group, no supplementation | Other | Other: Control no supplementationControl group, not taking any supplementation, only completing basic training activities |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Enrolled into British Army basic training
- Medically fit to train and complete the load carriage test
Key exclusion criteria (2 listed)
- Not taking any other nutritional supplement
- Pregnant
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 |
|---|---|---|
| High protein intakeThe participants received a 60g whey protein bolus each evening prior to sleep pre and post a military load carriage test. | Dietary supplement | High protein intake supplementation |
| Moderate protein intakeThe participants received a 20g whey protein bolus each evening prior to sleep pre and post a military load carriage test. | Dietary supplement | Moderate protein intake supplementation |
| Carbohydrate maltodextrin placeboThe participants received an isocaloric carbohydrate bolus each evening prior to sleep pre and post a military load carriage test. | Dietary supplement | Carbohydrate placebo |
| Control no supplementationControl group, no supplementation, only basic training | Other | Control group, no supplementation |
Primary outcome
Change in lower body muscle function
Time frame: 40-hours
The change in maximal vertical jump height in participants before and after the load carriage test
3 secondary outcomes
The change in urinary myoglobin
Time frame: 40-hours
The change in urinary 3-methylhistidine
Time frame: 40-hours
The change in perceived muscle soreness
Time frame: 40-hours
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 26 Feb 2024.
- Individual participant dataSharing planned: No
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.
Justin D Roberts, PhD principal investigator
Anglia Ruskin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High protein intake and Moderate protein intake in people with Protein-energy; Imbalance and Muscle Soreness, run by Anglia Ruskin University at 1 site in United Kingdom.
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 2 inclusion and 2 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 26 Feb 2024. 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 United Kingdom. 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 lower body muscle function (time frame: 40-hours). 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 26 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.