High Altitude Muscle Recovery

NCT06392373 | Completed

• 1 other identifier: 23-04H
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

To understand alterations in glycogen and molecular regulation of skeletal muscle glucose uptake, glycogen synthesis, and muscle protein recovery when consuming CHO (glucose) or CHO+PRO (glucose + whey) post-exercise during unacclimatized high altitude exposure, randomized crossover double blinded studies will be conducted in the hypobaric/hypoxic chamber at USARIEM Table 1. Briefly, the study consists of a 2 day baseline period at SL followed by two, 3 day trial periods (with the 3rd day being a testing day) at HA. The baseline is separated from trial 1 for a least a day, and trial 1 \& 2 separated by at least 4 days. Volunteers will consume CHO (glucose) or CHO+PRO (glucose + whey) drinks post-exercise during unacclimatized high altitude exposure during the two trial periods. The order of the drinks will be randomized (using a random number generator such as randomizer.org) and kept by a study staff not directly involved in data collection to maintain blinding.

Conditions

High Altitude

Outcome Measures

Primary Outcomes (2)

• Muscle Glycogen Concentrations

  Determine the effects of of consuming a CHO (1.2 g CHO/kg/hr) compared to an isocaloric CHO+PRO (0.9 g CHO/kg/hr + 0.3 g PRO/kg/hr) supplement on post exercise muscle glycogen concentrations (umol/kg dry muscle weight) during the initial 6 hours of aerobic exercise recovery

  6 hours

• Phosphorylation status of rpS6

  Determine the effects of of consuming a CHO (1.2 g CHO/kg/hr) compared to an isocaloric CHO+PRO (0.9 g CHO/kg/hr + 0.3 g PRO/kg/hr) supplement on post exercise muscle the fold change in the phosphorylation of rpS6 during the initial 6 hours of aerobic exercise recovery

  6 hours

Study Arms (2)

Carbohydrate plus protein

EXPERIMENTAL

Study beverages consumed over the initial 3 hours recovery phase from aerobic exercise, consuming 0.9g CHO/kg/hr + 0.3g PRO/kg/hr during high altitude exposure.

Dietary Supplement: CHO+PRO

Carbohydrate

ACTIVE COMPARATOR

Study beverages consumed over the initial 3 hours recovery phase from aerobic exercise, consuming1.2g CHO/kg/hr during high altitude exposure.

Dietary Supplement: CHO

Interventions

CHO+PRO DIETARY_SUPPLEMENT

0.9 g CHO/kg/hr + 0.3 g PRO/kg/hr

Carbohydrate plus protein

CHO DIETARY_SUPPLEMENT

1.2 g CHO/kg/hr

Carbohydrate

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged 18 - 39 years
• Physically active (exercise minimum 2-4 days per week)
• Have supervisor approval (permanent party military and civilians at NSSC)
• Willing to refrain from alcohol, nicotine products and dietary supplement use during the study
• Females must have normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or using oral/hormonal contraceptive use which contains low-dose estrogen/progesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos)
• Only consume caffeine products during the study if provided by study staff

You may not qualify if:

• Born at altitudes greater than 2,100 m (Subjects will inform the study team if they were born in Eagar AZ, Mammoth Lakes CA, CO, NM, UT, or WY).
• Musculoskeletal injuries that compromise exercise capability
• Metabolic or cardiovascular abnormalities, or gastrointestinal disorders (e.g. hypothyroidism, cardiovascular disease, Crohn's disease, etc.)
• Taking medication that affects macronutrient metabolism and/or the ability to participate in strenuous exercise (e.g. thyroxine, beta blockers, insulin etc.)
• Living in areas that are more than 1,200 m, or traveled to areas that are more than 1,200 m for five days or more within 2 months of data collection (e.g. Idaho Falls, ID; Denver, CO; etc.)
• Prior diagnosis of high-altitude pulmonary edema or high-altitude cerebral edema
• Presence of asthma or respiratory tract infections
• Smoking or vaping (other forms of nicotine users, i.e., chewing tobacco will not be excluded; individuals who quit smoking or vaping for more than 90 days may be included)
• Taking medications that interfere with oxygen delivery and transport (e.g. albuterol, EPO, etc.)
• Hematocrit (HCT) \<41% and Hemoglobin (HBG) \<13.5 g/dL(Males), HCT \<36% and HBG \<12.0 g/dL (Females), and Sickle Cell Anemia/Trait
• Whole blood donation within 8 weeks of the study
• Unwilling or unable to only consume study diets or foods provided due to personal preference, dietary restrictions, and/or food allergies
• Unwilling or unable to adhere to study physical restrictions (abstain from exercise or recreational activities i.e., pick-up basketball during the study procedures)
• Pregnant, trying to become pregnant, and/or breastfeeding (results of urine pregnancy test or self-report for breastfeeding will be obtained before body composition testing)

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead

Study Sites (1)

USARIEM

Natick, Massachusetts, 01760, United States

Location

MeSH Terms

Conditions

Altitude Sickness

Interventions

CVS 1123

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Double blinded randomized crossover design

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: October 1, 2023
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)