Lean Body Mass Response to Higher-protein Diets During Winter Military Training

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02327208
• Date of registration: 17/12/2014
• Prospective Registration: Yes
• Primary sponsor: United States Army Research Institute of Environmental Medicine
• Public title: Lean Body Mass Response to Higher-protein Diets During Winter Military Training
• Scientific title: Effects of Carbohydrate and Protein Supplementation on Whole-body Protein Balance and Skeletal Muscle Mass During Winter Military Training: a Randomized Controlled Trial
• Date of first enrolment: January 2015
• Target sample size: 73
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02327208
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Norway, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female Norwegian Soldiers aged 18 years or older participating in the 4-day
training program.

Exclusion Criteria:

- History of skin irritation (e.g., nickel or adhesive allergy), difficulty swallowing
large pills, and allergies to dairy products



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Body Weight

Intervention(s)

Dietary Supplement: Control

Dietary Supplement: Protein

Dietary Supplement: Carbohydrate

Primary Outcome(s)

Skeletal Muscle Mass [Time Frame: day 5]

Protein Balance [Time Frame: day 5]

Body weight [Time Frame: day 5]

Lean Body Mass [Time Frame: day 5]

Secondary Outcome(s)

Intestinal health [Time Frame: day 5]

Thermal and Physiological Strain [Time Frame: average 6 days]

Secondary ID(s)

14-33HC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors