Protein-energy; ImbalanceNCT05998590
Pre-sleep Protein Supplementation in British Army Recruits
A study testing High protein supplement and Moderate protein supplement in people with Protein-energy; Imbalance and Recovery, run by Anglia Ruskin University at 1 site in United Kingdom.
Trial 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. 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, Recovery, Body Weight
- What is being tested?
- High protein supplement and Moderate protein supplement
- 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 start Army training
Who cannot join
- Not taking any other nutritional supplement
- Not currently pregnant
- Not dairy or lactose intolerant or have any specific dietary requirements .
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 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.
Read the 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.
- Conditions
- Protein-energy; Imbalance, Recovery, Body Weight
- Being tested
- High protein supplement, Moderate protein supplement, Carbohydrate placebo, Control: No supplementation
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein supplementDietary supplement
The participants received a 60g protein bolus each evening prior to sleep from week 3 to week 12 of training.
Moderate protein supplementDietary supplement
The participants received a 20g protein bolus each evening prior to sleep from week 3 to week 12 of training.
Carbohydrate placeboDietary supplement
The participants received an isocaloric carbohydrate bolus each evening prior to sleep from week 3 to week 12 of training.
Control: No supplementationOther
The participants did not receive any supplementation but instead acted as a control group doing BT only
| Study group | Role | What they receive |
|---|---|---|
| High protein intake supplementation | Experimental | A daily 60g dose of whey protein supplementation received between 8-9pm during BT. Receives: Dietary Supplement: High protein supplement |
| Moderate protein intake supplementation | Experimental | A daily 20g dose of whey protein supplementation received between 8-9pm during BT. Receives: Dietary Supplement: Moderate protein supplement |
| Carbohydrate placebo supplementation | Placebo comparator | A daily isocaloric carbohydrate (maltodextrin) placebo received between 8-9pm during BT. Receives: Dietary Supplement: Carbohydrate placebo |
| Control group | Other | Control group, no daily supplement received, only participating in BT. Receives: Other: Control: No supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower body strength performance
Mid-thigh pull
Measured: 12 weeks
Secondary outcomes (1)
Body composition
Fat-free mass
Measured: 12 weeks
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- NCT05998590
- Sponsor's protocol ID
- 1076/MODREC/20
- Status last verified
- Jul 2023
- First submitted
- 3 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chapman S, Roberts J, Roberts AJ, Ogden H, Izard R, Smith L, Chichger H, Struszczak L, Rawcliffe AJ. Pre-sleep protein supplementation does not improve performance, body composition, and recovery in British Army recruits (part 1). Front Nutr. 2023 Nov 30;10:1262044. doi: 10.3389/fnut.2023.1262044. eCollection 2023.
PubMed 38144428
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-sleep Protein Supplementation Does Not Improve Performance, Body Composition and Recovery in British Army Recruits
- ClinicalTrials.gov ID
- NCT05998590
- Acronym / sponsor ID
- 1076/MODREC/20
- Conditions
- Protein-energy; Imbalance, Recovery, Body Weight
- 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.
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.
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 supplementA daily 60g dose of whey protein supplementation received between 8-9pm during BT. |
| Moderate protein intake supplementation | Experimental | Dietary Supplement: Moderate protein supplementA daily 20g dose of whey protein supplementation received between 8-9pm during BT. |
| Carbohydrate placebo supplementation | Placebo comparator | Dietary Supplement: Carbohydrate placeboA daily isocaloric carbohydrate (maltodextrin) placebo received between 8-9pm during BT. |
| Control group | Other | Other: Control: No supplementationControl group, no daily supplement received, only participating in BT. |
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 start Army training
Key exclusion criteria (3 listed)
- Not taking any other nutritional supplement
- Not currently pregnant
- Not dairy or lactose intolerant or have any specific dietary requirements .
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 supplementThe participants received a 60g protein bolus each evening prior to sleep from week 3 to week 12 of training. | Dietary supplement | High protein intake supplementation |
| Moderate protein supplementThe participants received a 20g protein bolus each evening prior to sleep from week 3 to week 12 of training. | Dietary supplement | Moderate protein intake supplementation |
| Carbohydrate placeboThe participants received an isocaloric carbohydrate bolus each evening prior to sleep from week 3 to week 12 of training. | Dietary supplement | Carbohydrate placebo supplementation |
| Control: No supplementationThe participants did not receive any supplementation but instead acted as a control group doing BT only | Other | Control group |
Primary outcome
Lower body strength performance
Time frame: 12 weeks
Mid-thigh pull
1 secondary outcome
Body composition
Time frame: 12 weeks
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 21 Aug 2023.
- Derived from this study: PubMed 38144428Chapman S, Roberts J, Roberts AJ, Ogden H, Izard R, Smith L, Chichger H, Struszczak L, Rawcliffe AJ. Pre-sleep protein supplementation does not improve performance, body composition, and recovery in British Army recruits (part 1). Front Nutr. 2023 Nov 30;10:1262044. doi: 10.3389/fnut.2023.1262044. eCollection 2023.
- 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 supplement and Moderate protein supplement in people with Protein-energy; Imbalance and Recovery, 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 3 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 21 Aug 2023. 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?
Lower body strength performance (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05998590, which also lists 1 linked publication.
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 21 Aug 2023.