Weight LossNCT02731066
Substrate Utilization, Exercise Performance, and Skeletal Muscle Response to Energy Deficit and Altitude Acclimatization
A study testing Standard pro, High pro and carbo bev in people with Weight Loss and Other Effects of High Altitude, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial summary
This research will evaluate nutrition requirements for missions at high altitude (i.e. >7800 feet above sea level) and the information obtained can be used to optimize nutrient content specifications for combat rations. The objectives are: 1. Read more about this study
- Who is it for?
- Ages 18 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Other Effects of High Altitude
- What is being tested?
- Standard pro, High pro and carbo bev
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Sep 2016
- 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 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Born at altitudes less than 2,100 m (~7,000 feet)
- Physically active based on assessment of physical activity history (2-4 days per week aerobic and/or resistance exercise)
- Body weight ≥ 110 lbs.
- Body mass index (BMI) between 18.5-29.9 kg/m2
- Females must be on contraception (e.g., oral birth control, NuvaRing®, Depo Provera®, etc.)
- Have supervisor approval (permanent party military)
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- Not taking any medications and/or willing to refrain from all medication use 4 wk prior to and throughout the entire study period, unless provided/approved by the US Army Research Institute of Environmental Medicine (USARIEM) Office of Medical Support and Oversight (OMSO) or medical oversight at Pikes Peak, Colorado organized through OMSO.
- Willing to refrain from alcohol, smoking any nicotine product (includes e-cigarettes), electronic cigarettes, chewing tobacco, caffeine, and dietary supplement use throughout the entire study period
- Willing to travel to USARIEM's Altitude Laboratory at Pikes Peak and live there for 22 consecutive days
- Refrain from taking any nonsteroidal anti-inflammatory drugs (NSAIDs; e.g. aspirin, Advil®, Aleve®, Naprosyn®, or any aspirin-containing product) for 10 days before and at least 5 days AFTER each muscle biopsy. (*Tylenol® or acetaminophen is ok to use if needed for discomfort)
Who cannot join
- Born at altitudes greater than 2,100 m (~7,000 feet)
- Living in areas that are more than 1,200 m (~4,000 feet), or have traveled to areas that are more than 1,200 m for five days or more within the last 2 mo
- Musculoskeletal injuries that compromise exercise capability
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
- Disease or medication that affects macronutrient metabolism and/or the ability to participate in strenuous exercise
- Evidence of apnea or other sleeping disorders
Show all 19Show fewer
- Evidence of prior high altitude pulmonary edema or high altitude cerebral edema diagnosis
- Allergies or intolerance to foods (including but not limited to lactose intolerance/milk allergy), vegetarian practices, or medications (including, but not limited to, lidocaine or phenylalanine) to be utilized in the study
- History of complications with lidocaine
- Taking medications that interfere with oxygen delivery and transport (Includes sedatives, sleeping aids, tranquilizers and/or any medication that depresses ventilation, diuretics, alpha and beta blockers)
- Evidence of any physical, mental, and/or medical conditions that would make the proposed studies relatively more hazardous as determined by OMSO
- Present condition of alcoholism, anabolic steroids, or other substance abuse issues
- Anemia (hematocrit <38% for males, <36% for females, and hemoglobin >12.5 g/dL for all subjects) or Sickle Cell Anemia/Trait
- Abnormal prothrombin time/partial thromboplastin time (PT/PTT) test or problems with blood clotting
- Blood donation within 8 weeks of beginning the study
- Pregnancy and women not on contraceptives
- Any use of antibiotics, except topical antibiotics, within 3 months of study participation.
- Colonoscopy within 3 months of study participation
- Use of laxatives, stool softeners, or anti-diarrheal medications at least once a week.
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760
About this study
This research will evaluate nutrition requirements for missions at high altitude (i.e. >7800 feet above sea level) and the information obtained can be used to optimize nutrient content specifications for combat rations.
The objectives are:
- Determine whether loss of lean body mass resulting from negative calorie balance over a 22-d period at high altitude can be prevented by increasing dietary protein intake.
- Determine the efficacy of carbohydrate (glucose and fructose) supplementation on aerobic exercise performance at sea level, acute exposure to high altitude, and in response to 22-d period of negative calorie balance at high altitude.
- Determine cognitive function, sleep patterns, and behavioral responses to high altitude and underfeeding.
- Determine appetite and eating behavior in response to high altitude and sustained underfeeding.
- Examine the effects of high altitude, negative calorie balance, dietary intake manipulations on gut health.
Read the detailed description
Twenty-four, normal to overweight (body mass index of 18.5-29.9 kg/m2), physically active adult civilians or active duty military personnel will be recruited for the 44-d protocol, 22-d at sea level and 22-d at high altitude (HA). During the 22-d sea level phase, volunteers will receive dietary counseling to maintain baseline weight and consume protein at levels consistent with recommendations for periods of low physical activity (1.0 g/kg/d). During the 22-d at HA, all meals and beverages (water ad libitum) will be prepared and provided to volunteers by research staff. Physical activity will be increased at HA and calorie intake will be reduced 40% to create a state of negative calorie balance.
Changes in total body, lean body, and fat mass will be assessed at sea level and after a 22-d energy deficit at HA. Regulation of muscle mass will be assessed using stable isotope methodology, muscle biopsies, and various molecular techniques, to directly measure muscle protein synthesis, whole body protein balance, and the cellular mechanisms that regulate these processes. Furthermore, exercise testing, substrate oxidation rates, and expired carbon dioxide labeled with the stable isotope of carbon dioxide (one extra neutron) will be used to assess total, exogenous, and endogenous carbohydrate oxidation and performance capacity.
A comprehensive cognitive/behavioral test battery will be performed at sea level and HA. Sleep will be assessed by actigraphy. Eating behavior and appetite will be assessed at sea level, acute HA, and after the 22-d energy deficit at HA using validated measures. Gut health will be assessed using sugar absorption tests and the bacterial composition of the gut will be characterized using advanced molecular techniques.
- Conditions
- Weight Loss, Other Effects of High Altitude
- Being tested
- Standard pro, High pro, carbo bev, placebo bev
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard proOther
Volunteers will receive dietary protein at 1.0 ± 0.2 g/kg/d.
High proOther
Volunteers will receive dietary protein at 2.0 ± 0.2 g/kg/d.
carbo bevOther
During aerobic performance testing, volunteers will receive a beverage containing 80 g glucose + 65 g fructose consumed at a rate providing ~1.8 g carbohydrate/min.
placebo bevOther
During aerobic performance testing, volunteers will receive a volume and flavor-matched, non-nutritive placebo beverage.
| Study group | Role | What they receive |
|---|---|---|
| High pro, carbo bev | Experimental | Volunteers will receive dietary protein at 2.0 ± 0.2 g/kg/d within a 40% energy deficit diet. During aerobic performance testing, volunteers will receive a beverage containing 80 g glucose + 65 g fructose consumed at a rate providing ~1.8 g carbohydrate/min. Receives: Other: High pro; Other: carbo bev |
| Standard pro, carbo bev | Experimental | Volunteers will receive dietary protein at 1.0 ± 0.2 g/kg/d within a 40% energy deficit diet. During aerobic performance testing, volunteers will receive a beverage containing 80 g glucose + 65 g fructose consumed at a rate providing ~1.8 g carbohydrate/min. Receives: Other: Standard pro; Other: carbo bev |
| High pro, placebo bev | Experimental | Volunteers will receive dietary protein at 2.0 ± 0.2 g/kg/d within a 40% energy deficit diet. During aerobic performance testing, volunteers will receive a volume and flavor-matched, non-nutritive placebo beverage. Receives: Other: High pro; Other: placebo bev |
| Standard pro, placebo bev | Experimental | Volunteers will receive dietary protein at 1.0 ± 0.2 g/kg/d within a 40% energy deficit diet. During aerobic performance testing, volunteers will receive a volume and flavor-matched, non-nutritive placebo beverage. Receives: Other: Standard pro; Other: placebo bev |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lean body mass
Measured: baseline (sea level day 0), prior to altitude exposure (sea level day 20), after ~3 wk energy deficit diet at high altitude (high altitude day 19)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionSep 2016
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 Weight LossStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Collaborators
- Eastern Michigan University
- Responsible party
- Sponsor
- Investigators
- Stefan M Pasiakos, PhD, Principal investigator, US Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731066
- Sponsor's protocol ID
- 16-02-HC
- Status last verified
- Oct 2017
- First submitted
- 29 Mar 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Berryman CE, Young AJ, Karl JP, Kenefick RW, Margolis LM, Cole RE, Carbone JW, Lieberman HR, Kim IY, Ferrando AA, Pasiakos SM. Severe negative energy balance during 21 d at high altitude decreases fat-free mass regardless of dietary protein intake: a randomized controlled trial. FASEB J. 2018 Feb;32(2):894-905. doi: 10.1096/fj.201700915R. Epub 2018 Jan 3.
PubMed 29066613Hennigar SR, Berryman CE, Kelley AM, Anderson BJ, Young AJ, McClung JP, Pasiakos SM. High-Altitude Acclimatization Suppresses Hepcidin Expression During Severe Energy Deficit. High Alt Med Biol. 2020 Sep;21(3):232-236. doi: 10.1089/ham.2019.0109. Epub 2020 Apr 21.
PubMed 32316799Bradbury KE, Berryman CE, Wilson MA, Luippold AJ, Kenefick RW, Young AJ, Pasiakos SM. Effects of carbohydrate supplementation on aerobic exercise performance during acute high altitude exposure and after 22 days of acclimatization and energy deficit. J Int Soc Sports Nutr. 2020 Jan 9;17(1):4. doi: 10.1186/s12970-020-0335-2.
PubMed 31918720
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substrate Utilization, Exercise Performance, and Skeletal Muscle Response to Energy Deficit and Altitude Acclimatization
- ClinicalTrials.gov ID
- NCT02731066
- Acronym / sponsor ID
- 16-02-HC
- Conditions
- Weight Loss, Other Effects of High Altitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Collaborators
- Eastern Michigan University
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 Apr 2016 (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.
This research will evaluate nutrition requirements for missions at high altitude (i.e. >7800 feet above sea level) and the information obtained can be used to optimize nutrient content specifications for combat rations.
The objectives are:
- Determine whether loss of lean body mass resulting from negative calorie balance over a 22-d period at high altitude can be prevented by increasing dietary protein intake.
- Determine the efficacy of carbohydrate (glucose and fructose) supplementation on aerobic exercise performance at sea level, acute exposure to high altitude, and in response to 22-d period of negative calorie balance at high altitude.
- Determine cognitive function, sleep patterns, and behavioral responses to high altitude and underfeeding.
- Determine appetite and eating behavior in response to high altitude and sustained underfeeding.
- Examine the effects of high altitude, negative calorie balance, dietary intake manipulations on gut health.
Detailed description
Twenty-four, normal to overweight (body mass index of 18.5-29.9 kg/m2), physically active adult civilians or active duty military personnel will be recruited for the 44-d protocol, 22-d at sea level and 22-d at high altitude (HA). During the 22-d sea level phase, volunteers will receive dietary counseling to maintain baseline weight and consume protein at levels consistent with recommendations for periods of low physical activity (1.0 g/kg/d). During the 22-d at HA, all meals and beverages (water ad libitum) will be prepared and provided to volunteers by research staff. Physical activity will be increased at HA and calorie intake will be reduced 40% to create a state of negative calorie balance.
Changes in total body, lean body, and fat mass will be assessed at sea level and after a 22-d energy deficit at HA. Regulation of muscle mass will be assessed using stable isotope methodology, muscle biopsies, and various molecular techniques, to directly measure muscle protein synthesis, whole body protein balance, and the cellular mechanisms that regulate these processes. Furthermore, exercise testing, substrate oxidation rates, and expired carbon dioxide labeled with the stable isotope of carbon dioxide (one extra neutron) will be used to assess total, exogenous, and endogenous carbohydrate oxidation and performance capacity.
A comprehensive cognitive/behavioral test battery will be performed at sea level and HA. Sleep will be assessed by actigraphy. Eating behavior and appetite will be assessed at sea level, acute HA, and after the 22-d energy deficit at HA using validated measures. Gut health will be assessed using sugar absorption tests and the bacterial composition of the gut will be characterized using advanced molecular techniques.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High pro, carbo bev | Experimental | Other: High pro, Other: carbo bevVolunteers will receive dietary protein at 2.0 ± 0.2 g/kg/d within a 40% energy deficit diet. During aerobic performance testing, volunteers will receive a beverage containing 80 g glucose + 65 g fructose consumed at a rate providing ~1.8 g carbohydrate/min. |
| Standard pro, carbo bev | Experimental | Other: Standard pro, Other: carbo bevVolunteers will receive dietary protein at 1.0 ± 0.2 g/kg/d within a 40% energy deficit diet. During aerobic performance testing, volunteers will receive a beverage containing 80 g glucose + 65 g fructose consumed at a rate providing ~1.8 g carbohydrate/min. |
| High pro, placebo bev | Experimental | Other: High pro, Other: placebo bevVolunteers will receive dietary protein at 2.0 ± 0.2 g/kg/d within a 40% energy deficit diet. During aerobic performance testing, volunteers will receive a volume and flavor-matched, non-nutritive placebo beverage. |
| Standard pro, placebo bev | Experimental | Other: Standard pro, Other: placebo bevVolunteers will receive dietary protein at 1.0 ± 0.2 g/kg/d within a 40% energy deficit diet. During aerobic performance testing, volunteers will receive a volume and flavor-matched, non-nutritive placebo beverage. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Born at altitudes less than 2,100 m (~7,000 feet)
- Physically active based on assessment of physical activity history (2-4 days per week aerobic and/or resistance exercise)
- Body weight ≥ 110 lbs.
- Body mass index (BMI) between 18.5-29.9 kg/m2
- Females must be on contraception (e.g., oral birth control, NuvaRing®, Depo Provera®, etc.)
Key exclusion criteria (19 listed)
- Born at altitudes greater than 2,100 m (~7,000 feet)
- Living in areas that are more than 1,200 m (~4,000 feet), or have traveled to areas that are more than 1,200 m for five days or more within the last 2 mo
- Musculoskeletal injuries that compromise exercise capability
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
- Disease or medication that affects macronutrient metabolism and/or the ability to participate in strenuous exercise
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 |
|---|---|---|
| Standard proVolunteers will receive dietary protein at 1.0 ± 0.2 g/kg/d. | Other | Standard pro, carbo bev, Standard pro, placebo bev |
| High proVolunteers will receive dietary protein at 2.0 ± 0.2 g/kg/d. | Other | High pro, carbo bev, High pro, placebo bev |
| carbo bevDuring aerobic performance testing, volunteers will receive a beverage containing 80 g glucose + 65 g fructose consumed at a rate providing ~1.8 g carbohydrate/min. | Other | High pro, carbo bev, Standard pro, carbo bev |
| placebo bevDuring aerobic performance testing, volunteers will receive a volume and flavor-matched, non-nutritive placebo beverage. | Other | High pro, placebo bev, Standard pro, placebo bev |
Primary outcome
Change in lean body mass
Time frame: baseline (sea level day 0), prior to altitude exposure (sea level day 20), after ~3 wk energy deficit diet at high altitude (high altitude day 19)
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 6 Nov 2017.
- Results publication: PubMed 29066613Berryman CE, Young AJ, Karl JP, Kenefick RW, Margolis LM, Cole RE, Carbone JW, Lieberman HR, Kim IY, Ferrando AA, Pasiakos SM. Severe negative energy balance during 21 d at high altitude decreases fat-free mass regardless of dietary protein intake: a randomized controlled trial. FASEB J. 2018 Feb;32(2):894-905. doi: 10.1096/fj.201700915R. Epub 2018 Jan 3.
- Derived from this study: PubMed 32316799Hennigar SR, Berryman CE, Kelley AM, Anderson BJ, Young AJ, McClung JP, Pasiakos SM. High-Altitude Acclimatization Suppresses Hepcidin Expression During Severe Energy Deficit. High Alt Med Biol. 2020 Sep;21(3):232-236. doi: 10.1089/ham.2019.0109. Epub 2020 Apr 21.
- Derived from this study: PubMed 31918720Bradbury KE, Berryman CE, Wilson MA, Luippold AJ, Kenefick RW, Young AJ, Pasiakos SM. Effects of carbohydrate supplementation on aerobic exercise performance during acute high altitude exposure and after 22 days of acclimatization and energy deficit. J Int Soc Sports Nutr. 2020 Jan 9;17(1):4. doi: 10.1186/s12970-020-0335-2.
- Individual participant dataSharing planned: Undecided
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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, PhD principal investigator
US Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard pro, High pro and carbo bev in people with Weight Loss and Other Effects of High Altitude, 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 10 inclusion and 19 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 6 Nov 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. 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 (time frame: baseline (sea level day 0), prior to altitude exposure (sea level day 20), after ~3 wk energy deficit diet at high altitude (high altitude day 19)). 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 NCT02731066, 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 6 Nov 2017; AzTrials last refreshed its copy on 30 Oct 2026.