- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05998603
Pre-sleep Protein Supplementation and Load Carriage Recovery in British Army Recruits
February 23, 2024 updated by: Anglia Ruskin University
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
122
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, United Kingdom, CB1 1PT
- Anglia Ruskin University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Enrolled into British Army basic training
- Medically fit to train and complete the load carriage test
Exclusion Criteria:
- Not taking any other nutritional supplement
- Pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High protein intake supplementation
A 60g daily dose of whey protein supplementation
|
The participants received a 60g whey protein bolus each evening prior to sleep pre and post a military load carriage test.
|
|
Experimental: Moderate protein intake supplementation
A 20g dose of whey protein supplementation
|
The participants received a 20g whey protein bolus each evening prior to sleep pre and post a military load carriage test.
|
|
Placebo Comparator: Carbohydrate placebo
An isocaloic maltodextrin carbohydrate placebo
|
The participants received an isocaloric carbohydrate bolus each evening prior to sleep pre and post a military load carriage test.
|
|
Other: Control group, no supplementation
Control group, not taking any supplementation, only completing basic training activities
|
Control group, no supplementation, only basic training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
40-hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change in urinary myoglobin
Time Frame: 40-hours
|
The relative change in concentration of urinary myoglobin (ng/ml) in participants before and after the load carriage test
|
40-hours
|
|
The change in urinary 3-methylhistidine
Time Frame: 40-hours
|
The relative change in concentration of urinary 3-methylhistidine (nmol/ml) in participants before and after the load carriage test
|
40-hours
|
|
The change in perceived muscle soreness
Time Frame: 40-hours
|
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).
|
40-hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Justin D Roberts, PhD, Anglia Ruskin University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2021
Primary Completion (Actual)
May 31, 2022
Study Completion (Actual)
May 31, 2022
Study Registration Dates
First Submitted
August 3, 2023
First Submitted That Met QC Criteria
August 11, 2023
First Posted (Actual)
August 21, 2023
Study Record Updates
Last Update Posted (Estimated)
February 26, 2024
Last Update Submitted That Met QC Criteria
February 23, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1076/MODREC/20B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.