Body WeightNCT02327208
Lean Body Mass Response to Higher-protein Diets During Winter Military Training
A study testing Protein and Carbohydrate in people with Body Weight, run by United States Army Research Institute of Environmental Medicine at 3 sites in 2 countries.
Trial summary
The objectives of this study are to: 1) determine effects of a prototype recovery food product providing supplemental energy on whole-body protein balance, skeletal muscle mass, and biomarkers of physiological status and strain during winter military training, and 2) determine the extent to which varying macronutrient… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Body Weight
- What is being tested?
- Protein and Carbohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2015to Feb 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female Norwegian Soldiers aged 18 years or older participating in the 4-day training program.
Who cannot join
- History of skin irritation (e.g., nickel or adhesive allergy), difficulty swallowing large pills, and allergies to dairy products
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Norway2 sites
Norwegian Defense Research Establishment
Kjeller
Skjold Garrison
Skjold
United States1 site
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760
About this study
Official title: Effects of Carbohydrate and Protein Supplementation on Whole-body Protein Balance and Skeletal Muscle Mass During Winter Military Training: a Randomized Controlled Trial
The objectives of this study are to: 1) determine effects of a prototype recovery food product providing supplemental energy on whole-body protein balance, skeletal muscle mass, and biomarkers of physiological status and strain during winter military training, and 2) determine the extent to which varying macronutrient composition (protein-based [PRO] versus carbohydrate-based [CHO]) of the food product modulates the physiological consequences to strenuous military training.
Read the detailed description
Up to 120 Norwegian Soldiers from the 2nd Battalion, Brigade North, Norwegian Army stationed at Skjold Garrison will be enrolled in a 9-day, randomized controlled study. Using dietary analysis, body composition assessments, stable isotope methodologies, basic biochemical techniques, and measures of physiological strain, the effects of supplemental energy in the form of carbohydrate and protein on indices of muscle mass and physiological status will be assessed.
We hypothesize that consuming supplemental energy will attenuate the effects of severe energy deficit on inflammation, androgenic hormones, and whole-body protein retention, thereby protecting skeletal muscle mass. We expect that consuming PRO will promote a more favorable recovery than consuming CHO, as indicated by measures of increased whole-body protein synthesis and greater conservation of skeletal muscle mass.
- Conditions
- Body Weight
- Being tested
- Control, Protein, Carbohydrate
- Keywords
- Military Training, Whey Protein, Body Composition
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDietary supplement
Also called Placebo (Rations Only)
ProteinDietary supplement
Also called Protein Bar
CarbohydrateDietary supplement
Also called Granola Bar
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 3 Combat rations only per day. No additional experimental food items (those assigned to the active comparator groups will consume isoenergetic carbohydrate and protein-based food products). Receives: Dietary Supplement: Control |
| Protein | Active comparator | Consume 4 whey protein-based snack-bars in addition to 3 combat rations each day during training. Receives: Dietary Supplement: Protein |
| Carbohydrate | Active comparator | Consume 4 carbohydrate-based snack-bars in addition to 3 combat rations each day during training. Receives: Dietary Supplement: Carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein Balance
Whole-body nitrogen balance
Measured: day 5
Lean Body Mass
Body composition
Measured: day 5
Skeletal Muscle Mass
Isotopic estimates of muscle protein mass
Measured: day 5
Body weight
Measured: day 5
Secondary outcomes (2)
Intestinal health
Gut health
Measured: day 5
Thermal and Physiological Strain
Core and skin temperature, heart rate, respiration rate
Measured: average 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Stefan Pasiakos, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327208
- Sponsor's protocol ID
- 14-33HC
- Status last verified
- Apr 2015
- First submitted
- 17 Dec 2014
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Karl JP, Margolis LM, Madslien EH, Murphy NE, Castellani JW, Gundersen Y, Hoke AV, Levangie MW, Kumar R, Chakraborty N, Gautam A, Hammamieh R, Martini S, Montain SJ, Pasiakos SM. Changes in intestinal microbiota composition and metabolism coincide with increased intestinal permeability in young adults under prolonged physiological stress. Am J Physiol Gastrointest Liver Physiol. 2017 Jun 1;312(6):G559-G571. doi: 10.1152/ajpgi.00066.2017. Epub 2017 Mar 23.
PubMed 28336545Margolis LM, Murphy NE, Martini S, Gundersen Y, Castellani JW, Karl JP, Carrigan CT, Teien HK, Madslien EH, Montain SJ, Pasiakos SM. Effects of Supplemental Energy on Protein Balance during 4-d Arctic Military Training. Med Sci Sports Exerc. 2016 Aug;48(8):1604-12. doi: 10.1249/MSS.0000000000000944.
PubMed 27054679Pasiakos SM, Margolis LM, Murphy NE, McClung HL, Martini S, Gundersen Y, Castellani JW, Karl JP, Teien HK, Madslien EH, Stenberg PH, Young AJ, Montain SJ, McClung JP. Effects of exercise mode, energy, and macronutrient interventions on inflammation during military training. Physiol Rep. 2016 Jun;4(11):e12820. doi: 10.14814/phy2.12820.
PubMed 27273884
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
- Effects of Carbohydrate and Protein Supplementation on Whole-body Protein Balance and Skeletal Muscle Mass During Winter Military Training: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02327208
- Acronym / sponsor ID
- 14-33HC
- Conditions
- Body Weight
- Keywords
- Military Training, Whey Protein, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- Jan 2015
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 Dec 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 objectives of this study are to: 1) determine effects of a prototype recovery food product providing supplemental energy on whole-body protein balance, skeletal muscle mass, and biomarkers of physiological status and strain during winter military training, and 2) determine the extent to which varying macronutrient composition (protein-based [PRO] versus carbohydrate-based [CHO]) of the food product modulates the physiological consequences to strenuous military training.
Detailed description
Up to 120 Norwegian Soldiers from the 2nd Battalion, Brigade North, Norwegian Army stationed at Skjold Garrison will be enrolled in a 9-day, randomized controlled study. Using dietary analysis, body composition assessments, stable isotope methodologies, basic biochemical techniques, and measures of physiological strain, the effects of supplemental energy in the form of carbohydrate and protein on indices of muscle mass and physiological status will be assessed.
We hypothesize that consuming supplemental energy will attenuate the effects of severe energy deficit on inflammation, androgenic hormones, and whole-body protein retention, thereby protecting skeletal muscle mass. We expect that consuming PRO will promote a more favorable recovery than consuming CHO, as indicated by measures of increased whole-body protein synthesis and greater conservation of skeletal muscle mass.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Control3 Combat rations only per day. No additional experimental food items (those assigned to the active comparator groups will consume isoenergetic carbohydrate and protein-based food products). |
| Protein | Active comparator | Dietary Supplement: ProteinConsume 4 whey protein-based snack-bars in addition to 3 combat rations each day during training. |
| Carbohydrate | Active comparator | Dietary Supplement: CarbohydrateConsume 4 carbohydrate-based snack-bars in addition to 3 combat rations each day during training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female Norwegian Soldiers aged 18 years or older participating in the 4-day training program.
Key exclusion criteria (1 listed)
- History of skin irritation (e.g., nickel or adhesive allergy), difficulty swallowing large pills, and 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 |
|---|---|---|
| ControlAlso: Placebo (Rations Only) | Dietary supplement | Control |
| ProteinAlso: Protein Bar | Dietary supplement | Protein |
| CarbohydrateAlso: Granola Bar | Dietary supplement | Carbohydrate |
Primary outcome
Protein Balance
Time frame: day 5
Whole-body nitrogen balance
Lean Body Mass
Time frame: day 5
Body composition
Skeletal Muscle Mass
Time frame: day 5
Isotopic estimates of muscle protein mass
Body weight
Time frame: day 5
2 secondary outcomes
Intestinal health
Time frame: day 5
Thermal and Physiological Strain
Time frame: average 6 days
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 28336545Karl JP, Margolis LM, Madslien EH, Murphy NE, Castellani JW, Gundersen Y, Hoke AV, Levangie MW, Kumar R, Chakraborty N, Gautam A, Hammamieh R, Martini S, Montain SJ, Pasiakos SM. Changes in intestinal microbiota composition and metabolism coincide with increased intestinal permeability in young adults under prolonged physiological stress. Am J Physiol Gastrointest Liver Physiol. 2017 Jun 1;312(6):G559-G571. doi: 10.1152/ajpgi.00066.2017. Epub 2017 Mar 23.
- Results publication: PubMed 27054679Margolis LM, Murphy NE, Martini S, Gundersen Y, Castellani JW, Karl JP, Carrigan CT, Teien HK, Madslien EH, Montain SJ, Pasiakos SM. Effects of Supplemental Energy on Protein Balance during 4-d Arctic Military Training. Med Sci Sports Exerc. 2016 Aug;48(8):1604-12. doi: 10.1249/MSS.0000000000000944.
- Results publication: PubMed 27273884Pasiakos SM, Margolis LM, Murphy NE, McClung HL, Martini S, Gundersen Y, Castellani JW, Karl JP, Teien HK, Madslien EH, Stenberg PH, Young AJ, Montain SJ, McClung JP. Effects of exercise mode, energy, and macronutrient interventions on inflammation during military training. Physiol Rep. 2016 Jun;4(11):e12820. doi: 10.14814/phy2.12820.
Related trials for Body Weight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein and Carbohydrate in people with Body Weight, run by United States Army Research Institute of Environmental Medicine at 3 sites in 2 countries.
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 3 sites in Norway, 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?
Protein Balance (time frame: day 5). The study lists 4 primary outcomes in all. 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 NCT02327208, which also lists 3 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.