- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05998590
Pre-sleep Protein Supplementation in British Army Recruits
August 11, 2023 updated by: Anglia Ruskin University
Pre-sleep Protein Supplementation Does Not Improve Performance, Body Composition and Recovery in British Army Recruits
Dietary protein has been shown to be important to support physical training.
For occupational demands such as military training, new recruits often fail to meet the recommended protein intake during basic training (BT), with negligible amounts consumed in the evening.
As such, individuals undertaking BT may require higher intakes than the general population.This study assessed the influence of a daily bolus of protein prior to sleep on performance adaptations, body composition and recovery in British Army recruits.
Study Overview
Status
Completed
Conditions
Detailed Description
Dietary protein is crucial for optimising physical training adaptations such as muscular strength and mass, which are key aims for athletic populations, including British Army recruits.
New recruits fail to meet the recommended protein intake during basic training (BT), with negligible amounts consumed in the evening.
This study aimed to assess the influence of a daily bolus of protein prior to sleep on performance adaptations, body composition and recovery in British Army recruits.
The study will recruit a mixed cohort of >120 new recruits from the United Kingdom (UK) British Army who will be randomised into a dietary control (CON), carbohydrate placebo (PLA), moderate (20g) protein (MOD) or high (60g) protein (HIGH) supplementation group.
Supplements will be isocaloric and consumed daily on weekday evenings between 2000 and 2100h for 10 weeks during BT, alongside standardised dietary intake and BT activities.
Performance tests (mid-thigh pull, medicine ball throw, 2km run time, maximal push-up and maximal vertical jump) and body composition will be assessed at the start and end of BT under standardised conditions.
Dietary intake, energy expenditure, salivary hormones, urinary nitrogen balance, perceived muscle soreness, rating of perceived exertion, mood and fatigue will be assessed at the start, middle and end of BT.
The underlying aim of this study is to assess whether inclusion of nocturnal protein supplementation will influence performance adaptations, body composition changes or acute recovery in British Army recruits.
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 start Army training
Exclusion Criteria:
- Not taking any other nutritional supplement
- Not currently pregnant
- Not dairy or lactose intolerant or have any specific dietary requirements .
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 daily 60g dose of whey protein supplementation received between 8-9pm during BT.
|
The participants received a 60g protein bolus each evening prior to sleep from week 3 to week 12 of training.
|
Experimental: Moderate protein intake supplementation
A daily 20g dose of whey protein supplementation received between 8-9pm during BT.
|
The participants received a 20g protein bolus each evening prior to sleep from week 3 to week 12 of training.
|
Placebo Comparator: Carbohydrate placebo supplementation
A daily isocaloric carbohydrate (maltodextrin) placebo received between 8-9pm during BT.
|
The participants received an isocaloric carbohydrate bolus each evening prior to sleep from week 3 to week 12 of training.
|
Other: Control group
Control group, no daily supplement received, only participating in BT.
|
The participants did not receive any supplementation but instead acted as a control group doing BT only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lower body strength performance
Time Frame: 12 weeks
|
Mid-thigh pull
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body composition
Time Frame: 12 weeks
|
Fat-free mass
|
12 weeks
|
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 (Actual)
August 21, 2023
Last Update Submitted That Met QC Criteria
August 11, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1076/MODREC/20
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.
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