Physiological Response to Protein and Energy-enhanced Food Products During Winter Military Training

Weight Loss Clinical Trial

Official title:

Physiological Efficacy and Acceptability of Essential Amino Acid-enhanced and Energy Density-enhanced Combat Ration Products During Multi-stressor Operations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05210205
• Other study ID #: 21-19HC
• Status: Completed
• Phase: N/A
• Start date: March 13, 2022
• Est. completion date: March 26, 2022

Study information

• Verified date: May 2022
• Source: United States Army Research Institute of Environmental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Soldiers commonly lose muscle mass during training and combat operations that produce large energy deficits (i.e., calories burned > calories consumed). Developing new combat ration products that increase energy intake (i.e., energy dense foods) or the amount and quality of protein consumed (i.e., essential amino acid [EAA] content) may prevent muscle breakdown and stimulate muscle repair and muscle maintenance during unavoidable energy deficit. The primary objective of this study is to determine the effects of prototype recovery food products that are energy dense or that provide increased amounts of EAAs (anabolic component of dietary protein) on energy balance, whole-body net protein balance, and indices of physiological status during strenuous winter military training.

Description:

Up to 96 Norwegian Soldiers participating in a winter training exercise at the Garrison in Sør-Varanger (GSV) will be enrolled in an approximately 11-day, randomized controlled study. Participants will be randomly assigned at the beginning of the training exercise to groups provided 3 Norwegian Army arctic combat rations and approximately 1500 supplemental calories from food products with increased energy density (EN-DENSE), increased essential amino acids (EAA), or low energy density (CONTROL) each day. Participants will be instructed to consume all of the supplemental food products provided to them and consume the arctic combat rations ad libitum. The effect of consuming EN-DENSE, EAA, or CONTROL food products during strenuous military training on physiological status and recovery will be assessed using dietary analysis, stable isotope methodologies, physical performance measures, gut health analyses, blood sampling, and questionnaires. This design will test the hypothesis that 1) EN-DENSE ration products will attenuate the energy deficit during the training, thereby limiting whole-body protein losses and decrements in physiological status; and 2) the protein-sparing benefit of EAA will limit whole-body protein loss regardless of the energy deficit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 26, 2022
• Est. primary completion date: March 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Male and female Norwegian Soldiers aged 18 years or older participating in the winter training exercise at the Garrison in Sør-Varanger.

Exclusion Criteria:

• Any injury or health condition limiting full participation in the training program.
• Allergies or intolerance to foods used in the study (including but not limited to lactose intolerance/milk allergy) or vegetarian practices.

Related Conditions & MeSH terms

• Fractures, Stress
• Malnutrition
• Malnutrition (Calorie)
• Military Operational Stress Reaction
• Muscle Wasting
• Muscular Atrophy
• Weight Loss

Intervention

Dietary Supplement:
• EAA
EAA-enhanced protein snack bars
• Energy Dense
Energy dense snack bars (same calories in a smaller volume of food)
• Control
Low energy dense snack bars (same calories in a greater volume of food)

Locations

Country	Name	City	State
Norway	Garrison in Sør-Varanger	Kirkenes

Sponsors (3)

Lead Sponsor	Collaborator
United States Army Research Institute of Environmental Medicine	Norwegian Defense Research Establishment, University of Arkansas

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein balance	Use stable isotope methodologies to measure whole-body protein balance	10 hours
Primary	Energy Expenditure	Use stable isotope methodologies to measure energy expenditure during the training exercise.	8 days
Primary	Energy intake	Use food logs and collect food wrappers to measure energy intake during the training exercise.	8 days
Secondary	Intestinal Permeability	Use dual sugar test (i.e., sucralose and erythritol) to measure intestinal permeability	24 hours
Secondary	Gut microbiome composition	Measure changes in fecal bacterial community, diversity, and relative abundance	Study days -1 and 9
Secondary	Vertical jump	Measure changes in physical performance as determined by a vertical jump test	Study day 0 and 9
Secondary	Pull Strength Test	Measure changes in physical performance as determined by a pull strength test	Study day 0 and 9