Military Operational Stress ReactionNCT02057094
Effects of Protein Supplementation on Lean Body Mass Recovery From Extreme Military Training
A study of Military Operational Stress Reaction and Malnutrition (Calorie), run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the physiological consequences of extreme military training and determine whether protein supplementation enhances recovery by promoting gains in lean body mass. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Military Operational Stress Reaction, Malnutrition (Calorie), Weight Loss
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Mar 2015
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- US Marines at least 18 years old, enrolled in US Marine SERE school
Who cannot join
- Self-reported allergies to dairy products
Trial locations and contacts
1 site in 1 country.
United States1 site
US Marine SERE School
Marine Corps Base Camp Lejeune, North Carolina, 28546
About this study
Official title: Effect of Protein Supplementation on Lean Body Mass Recovery and Physiological Resilience Following Survive, Evade, Resist, Escape (SERE) School
The purpose of this study is to evaluate the physiological consequences of extreme military training and determine whether protein supplementation enhances recovery by promoting gains in lean body mass. This study will be conducted at the US Marine Survive, Evade, Resist, Escape (SERE) school at Camp Lejeune, North Carolina.
SERE school may be an ideal setting to assess nutritional interventions that promote recovery from severe military operational stress, and identify innate or experiential variables that may lead to increased levels of resilience in Warfighters. Our laboratory has recently demonstrated the detrimental effects and stressful nature of SERE. Heart rates and stress-related hormones increased dramatically, with concomitant reductions in circulating anabolic hormones. Additionally, SERE causes significant weight loss (15-20 lbs), which probably included lean body mass. The effects of severe operational stress induced by SERE, particularly the loss of lean mass, may degrade physical performance, increase injury risk, and compromise military readiness. Under controlled laboratory conditions, consuming high protein diets or supplemental high-quality protein promotes muscle protein retention, enhances muscle protein synthesis, and protects lean body mass in response to stress. Whether consuming supplemental protein promotes lean mass recovery and physiological resilience following a 'real-world' military stress has not been determined. Further, the level of supplemental protein necessary to optimize recovery from extreme military operational stress has not been elucidated.
Read more
Up to 90 US Marines will be enrolled in a 46-day double-blind, placebo-controlled trial. Using complex body composition measurements, kinetic modeling of human metabolism, blood sampling and cognitive and nutrition questionnaires, the consequences of SERE and the efficacy of protein recovery nutrition on lean mass accretion and Warfighter resilience will be assessed.
We hypothesize that consuming a specially formulated, high-quality supplemental protein ration item will speed recovery of lean body mass, physiological, and psychological resilience following extreme military operational stress.
- Being tested
- Protein, High-Protein, and Control
- Medical subject headings
- Malnutrition, Weight Loss, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein, High-Protein, and ControlDietary supplement
Also called Whey and Casein protein, Carbohydrate-based control
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Dining facility recovery feeding only, no supplemental protein consumed (an isoenergetic, carbohydrate supplement will be consumed by those assigned to the Control group) Receives: Dietary Supplement: Protein, High-Protein, and Control |
| Protein | Active comparator | Consume dining facility food with:
2, 20 g whey protein supplements daily (for ~27 days)
1, 40 g casein protein supplement daily (for ~27 days) Receives: Dietary Supplement: Protein, High-Protein, and Control |
| High-Protein | Active comparator | Consume dining facility food with:
2, 40 g whey protein supplements daily (~27 days)
1, 50 g casein protein supplement daily (~27 days) Receives: Dietary Supplement: Protein, High-Protein, and Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lean body mass following SERE and recovery nutrition
Days 1-2: baseline Days 18-19: completion of SERE training Days 45-46: completion of a 26 day recovery nutrition intervention
Measured: days 1-2, days 18-19, and days 45-46
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Military Operational Stress ReactionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Stefan M Pasiakos, Ph.D., Principal investigator, USARIEM Military Nutrition Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057094
- Sponsor's protocol ID
- 14-02H
- Status last verified
- Apr 2015
- First submitted
- 5 Dec 2013
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Berryman CE, Sepowitz JJ, McClung HL, Lieberman HR, Farina EK, McClung JP, Ferrando AA, Pasiakos SM. Supplementing an energy adequate, higher protein diet with protein does not enhance fat-free mass restoration after short-term severe negative energy balance. J Appl Physiol (1985). 2017 Jun 1;122(6):1485-1493. doi: 10.1152/japplphysiol.01039.2016. Epub 2017 Apr 6.
PubMed 28385919Berryman CE, McClung HL, Sepowitz JJ, Gaffney-Stomberg E, Ferrando AA, McClung JP, Pasiakos SM. Testosterone status following short-term, severe energy deficit is associated with fat-free mass loss in U.S. Marines. Physiol Rep. 2022 Sep;10(18):e15461. doi: 10.14814/phy2.15461.
PubMed 36117330
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Protein Supplementation on Lean Body Mass Recovery and Physiological Resilience Following Survive, Evade, Resist, Escape (SERE) School
- ClinicalTrials.gov ID
- NCT02057094
- Acronym / sponsor ID
- 14-02H
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Feb 2014 (estimated)
- 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.
The purpose of this study is to evaluate the physiological consequences of extreme military training and determine whether protein supplementation enhances recovery by promoting gains in lean body mass. This study will be conducted at the US Marine Survive, Evade, Resist, Escape (SERE) school at Camp Lejeune, North Carolina.
SERE school may be an ideal setting to assess nutritional interventions that promote recovery from severe military operational stress, and identify innate or experiential variables that may lead to increased levels of resilience in Warfighters. Our laboratory has recently demonstrated the detrimental effects and stressful nature of SERE. Heart rates and stress-related hormones increased dramatically, with concomitant reductions in circulating anabolic hormones. Additionally, SERE causes significant weight loss (15-20 lbs), which probably included lean body mass. The effects of severe operational stress induced by SERE, particularly the loss of lean mass, may degrade physical performance, increase injury risk, and compromise military readiness. Under controlled laboratory conditions, consuming high protein diets or supplemental high-quality protein promotes muscle protein retention, enhances muscle protein synthesis, and protects lean body mass in response to stress. Whether consuming supplemental protein promotes lean mass recovery and physiological resilience following a 'real-world' military stress has not been determined. Further, the level of supplemental protein necessary to optimize recovery from extreme military operational stress has not been elucidated.
Up to 90 US Marines will be enrolled in a 46-day double-blind, placebo-controlled trial. Using complex body composition measurements, kinetic modeling of human metabolism, blood sampling and cognitive and nutrition questionnaires, the consequences of SERE and the efficacy of protein recovery nutrition on lean mass accretion and Warfighter resilience will be assessed.
We hypothesize that consuming a specially formulated, high-quality supplemental protein ration item will speed recovery of lean body mass, physiological, and psychological resilience following extreme military operational stress.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Protein, High-Protein, and ControlDining facility recovery feeding only, no supplemental protein consumed (an isoenergetic, carbohydrate supplement will be consumed by those assigned to the Control group) |
| Protein | Active comparator | Dietary Supplement: Protein, High-Protein, and ControlConsume dining facility food with: 2, 20 g whey protein supplements daily (for ~27 days) 1, 40 g casein protein supplement daily (for ~27 days) |
| High-Protein | Active comparator | Dietary Supplement: Protein, High-Protein, and ControlConsume dining facility food with: 2, 40 g whey protein supplements daily (~27 days) 1, 50 g casein protein supplement daily (~27 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- US Marines at least 18 years old, enrolled in US Marine SERE school
Key exclusion criteria (1 listed)
- Self-reported allergies to dairy products
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 |
|---|---|---|
| Protein, High-Protein, and ControlAlso: Whey and Casein protein, Carbohydrate-based control | Dietary supplement | Control, High-Protein, Protein |
Primary outcome
Change in lean body mass following SERE and recovery nutrition
Time frame: days 1-2, days 18-19, and days 45-46
Days 1-2: baseline Days 18-19: completion of SERE training Days 45-46: completion of a 26 day recovery nutrition intervention
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 Jul 2017.
- Background: PubMed 28385919Berryman CE, Sepowitz JJ, McClung HL, Lieberman HR, Farina EK, McClung JP, Ferrando AA, Pasiakos SM. Supplementing an energy adequate, higher protein diet with protein does not enhance fat-free mass restoration after short-term severe negative energy balance. J Appl Physiol (1985). 2017 Jun 1;122(6):1485-1493. doi: 10.1152/japplphysiol.01039.2016. Epub 2017 Apr 6.
- Derived from this study: PubMed 36117330Berryman CE, McClung HL, Sepowitz JJ, Gaffney-Stomberg E, Ferrando AA, McClung JP, Pasiakos SM. Testosterone status following short-term, severe energy deficit is associated with fat-free mass loss in U.S. Marines. Physiol Rep. 2022 Sep;10(18):e15461. doi: 10.14814/phy2.15461.
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PTSD, Military Activity
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.
Stefan M Pasiakos, Ph.D. principal investigator
USARIEM Military Nutrition Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Military Operational Stress Reaction and Malnutrition (Calorie), run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
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 1 inclusion and 1 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 Jul 2017. 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 States. 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?
Change in lean body mass following SERE and recovery nutrition (time frame: days 1-2, days 18-19, and days 45-46). 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 NCT02057094, which also lists 2 linked publications.
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 Jul 2017.