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

NCT ID: NCT05210205

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-13
• Study Completion Date: 2022-03-26

Brief 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.

Detailed 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.

Conditions

Military Operational Stress Reaction; Malnutrition (Calorie); Weight Loss; Muscle Wasting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

EAA-enhanced food products

Consume approximately 1500 calories of EAA-enhanced food products plus ad libitum consumption of 3 combat rations each day during training.

Group Type: EXPERIMENTAL

EAA

Intervention Type: DIETARY_SUPPLEMENT

EAA-enhanced protein snack bars

Energy dense food products

Consume approximately 1500 calories of energy dense food products plus ad libitum consumption of 3 combat rations each day during training.

Group Type: EXPERIMENTAL

Energy Dense

Intervention Type: DIETARY_SUPPLEMENT

Energy dense snack bars (same calories in a smaller volume of food)

Control food products

Consume approximately 1500 calories of low energy dense food products plus ad libitum consumption of 3 combat rations each day during training.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: DIETARY_SUPPLEMENT

Low energy dense snack bars (same calories in a greater volume of food)

Interventions

EAA

EAA-enhanced protein snack bars

Intervention Type: DIETARY_SUPPLEMENT

Energy Dense

Energy dense snack bars (same calories in a smaller volume of food)

Intervention Type: DIETARY_SUPPLEMENT

Control

Low energy dense snack bars (same calories in a greater volume of food)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norwegian Defense Research Establishment

UNKNOWN

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: collaborator

United States Army Research Institute of Environmental Medicine

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily E Howard, PhD

Role: PRINCIPAL_INVESTIGATOR

United States Army Research Institute of Environmental Medicine

Locations

Garrison in Sør-Varanger

Kirkenes, , Norway

Countries

Norway

Other Identifiers

21-19HC

Identifier Type: -

Identifier Source: org_study_id