NCT02731066

Brief 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. 1.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.
  2. 2.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.
  3. 3.Determine cognitive function, sleep patterns, and behavioral responses to high altitude and underfeeding.
  4. 4.Determine appetite and eating behavior in response to high altitude and sustained underfeeding.
  5. 5.Examine the effects of high altitude, negative calorie balance, dietary intake manipulations on gut health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

6 months

First QC Date

March 29, 2016

Last Update Submit

October 31, 2017

Conditions

Weight LossOther Effects of High Altitude

Outcome Measures

Primary Outcomes (1)

  • Change in lean body mass

    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)

Study Arms (4)

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.

Other: High proOther: 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.

Other: Standard proOther: 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.

Other: High proOther: 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.

Other: Standard proOther: placebo bev

Interventions

Standard proOTHER

Volunteers will receive dietary protein at 1.0 ± 0.2 g/kg/d.

Standard pro, carbo bevStandard pro, placebo bev
High proOTHER

Volunteers will receive dietary protein at 2.0 ± 0.2 g/kg/d.

High pro, carbo bevHigh pro, placebo bev
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.

High pro, carbo bevStandard pro, carbo bev
placebo bevOTHER

During aerobic performance testing, volunteers will receive a volume and flavor-matched, non-nutritive placebo beverage.

High pro, placebo bevStandard pro, placebo bev

Eligibility Criteria

Age18 Years - 42 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • 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)

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

Location

Related Publications (3)

  • 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.

    PMID: 29066613RESULT

  • Hennigar 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.

    PMID: 32316799DERIVED

  • Bradbury 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.

    PMID: 31918720DERIVED

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan M Pasiakos, PhD

    US Army Research Institute of Environmental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 7, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 6, 2017

Record last verified: 2017-10

Locations

US(1)