NCT05998603

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

August 3, 2023

Last Update Submit

February 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in lower body muscle function

    The change in maximal vertical jump height in participants before and after the load carriage test

    40-hours

Secondary Outcomes (3)

  • The change in urinary myoglobin

    40-hours

  • The change in urinary 3-methylhistidine

    40-hours

  • The change in perceived muscle soreness

    40-hours

Study Arms (4)

High protein intake supplementation

EXPERIMENTAL

A 60g daily dose of whey protein supplementation

Dietary Supplement: High protein intake

Moderate protein intake supplementation

EXPERIMENTAL

A 20g dose of whey protein supplementation

Dietary Supplement: Moderate protein intake

Carbohydrate placebo

PLACEBO COMPARATOR

An isocaloic maltodextrin carbohydrate placebo

Dietary Supplement: Carbohydrate maltodextrin placebo

Control group, no supplementation

OTHER

Control group, not taking any supplementation, only completing basic training activities

Other: Control no supplementation

Interventions

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.

High protein intake supplementation
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.

Moderate protein intake supplementation

The participants received an isocaloric carbohydrate bolus each evening prior to sleep pre and post a military load carriage test.

Carbohydrate placebo

Control group, no supplementation, only basic training

Control group, no supplementation

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Enrolled into British Army basic training
  • Medically fit to train and complete the load carriage test

You may not qualify if:

  • Not taking any other nutritional supplement
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anglia Ruskin University

Cambridge, Cambridgeshire, CB1 1PT, United Kingdom

Location

MeSH Terms

Conditions

Myalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Justin D Roberts, PhD

    Anglia Ruskin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 21, 2023

Study Start

May 1, 2021

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

February 26, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations