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Pre-sleep Protein Supplementation in British Army Recruits

Primary Purpose

Protein-energy; Imbalance, Recovery, Body Weight

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High protein supplement
Moderate protein supplement
Carbohydrate placebo
Control: No supplementation
Sponsored by
Anglia Ruskin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Protein-energy; Imbalance

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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 .

Sites / Locations

  • Anglia Ruskin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Other

Arm Label

High protein intake supplementation

Moderate protein intake supplementation

Carbohydrate placebo supplementation

Control group

Arm Description

A daily 60g dose of whey protein supplementation received between 8-9pm during BT.

A daily 20g dose of whey protein supplementation received between 8-9pm during BT.

A daily isocaloric carbohydrate (maltodextrin) placebo received between 8-9pm during BT.

Control group, no daily supplement received, only participating in BT.

Outcomes

Primary Outcome Measures

Lower body strength performance
Mid-thigh pull

Secondary Outcome Measures

Body composition
Fat-free mass

Full Information

First Posted
August 3, 2023
Last Updated
August 11, 2023
Sponsor
Anglia Ruskin University
Collaborators
University of Exeter
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1. Study Identification

Unique Protocol Identification Number
NCT05998590
Brief Title
Pre-sleep Protein Supplementation in British Army Recruits
Official Title
Pre-sleep Protein Supplementation Does Not Improve Performance, Body Composition and Recovery in British Army Recruits
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anglia Ruskin University
Collaborators
University of Exeter

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protein-energy; Imbalance, Recovery, Body Weight

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High protein intake supplementation
Arm Type
Experimental
Arm Description
A daily 60g dose of whey protein supplementation received between 8-9pm during BT.
Arm Title
Moderate protein intake supplementation
Arm Type
Experimental
Arm Description
A daily 20g dose of whey protein supplementation received between 8-9pm during BT.
Arm Title
Carbohydrate placebo supplementation
Arm Type
Placebo Comparator
Arm Description
A daily isocaloric carbohydrate (maltodextrin) placebo received between 8-9pm during BT.
Arm Title
Control group
Arm Type
Other
Arm Description
Control group, no daily supplement received, only participating in BT.
Intervention Type
Dietary Supplement
Intervention Name(s)
High protein supplement
Intervention Description
The participants received a 60g protein bolus each evening prior to sleep from week 3 to week 12 of training.
Intervention Type
Dietary Supplement
Intervention Name(s)
Moderate protein supplement
Intervention Description
The participants received a 20g protein bolus each evening prior to sleep from week 3 to week 12 of training.
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate placebo
Intervention Description
The participants received an isocaloric carbohydrate bolus each evening prior to sleep from week 3 to week 12 of training.
Intervention Type
Other
Intervention Name(s)
Control: No supplementation
Intervention Description
The participants did not receive any supplementation but instead acted as a control group doing BT only
Primary Outcome Measure Information:
Title
Lower body strength performance
Description
Mid-thigh pull
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body composition
Description
Fat-free mass
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin D Roberts, PhD
Organizational Affiliation
Anglia Ruskin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anglia Ruskin University
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB1 1PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Pre-sleep Protein Supplementation in British Army Recruits

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