## Protocol Section
### Identification Module
**NCT ID:** NCT01714479

**Brief Title:** Skeletal Muscle Response to Amino Acids and Load Carriage Exercise

**Official Title:** Skeletal Muscle and Physical Performance Responses to Leucine-Enriched Nutrition Supplementation During Load Carriage

#### Organization Study ID Info
**ID:** 12-18-HC
#### Organization
**Class:** FED
**Full Name:** United States Army Research Institute of Environmental Medicine
### Status Module
#### Completion Date
**Date:** 2013-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-07-21

**Type:** ACTUAL

**Last Update Submit Date:** 2017-07-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-11

**Type:** ACTUAL

#### Start Date
**Date:** 2012-10

**Status Verified Date:** 2016-09

#### Study First Post Date
**Date:** 2012-10-26
**Type:** ESTIMATED
**Study First Submit Date:** 2012-10-23
**Study First Submit QC Date:** 2012-10-25
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** US Army Natick Soldier Research, Development & Engineering Center

#### Lead Sponsor

**Class:** FED

**Name:** United States Army Research Institute of Environmental Medicine

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Warfighters often experience physical overload, as the uniform and associated gear that they carry burdens them with substantial loads. The loads increase energy expenditure to levels that exceed a Warfighter's typical energy intake. The typical assault load is approximately 25 kg, although loads as high as 55 kg are often carried, which when combined with extreme energy expenditures can degrade health and performance, and increase the risk of injury. Branched-chain amino acid (leucine) supplementation may confer protection against the negative effects of operational stress by stimulating muscle protein synthesis and reducing degradation. This study will determine if leucine-enriched nutrition supplementation confers protection against the negative consequences of sustained load carriage exercise, and explore the mechanisms by which leucine might impart protection.

### Conditions Module

**Conditions:**

- Muscle Loss

- Muscle Anabolism

- Muscle Performance

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Load Carriage - with a calorie-free placebo

**Intervention Names:**

- Other: Placebo

**Label:** Load Carriage - Control

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Load Carriage with leucine-enriched amino acid supplementation

**Intervention Names:**

- Other: Leucine-enriched nutritional supplement

**Label:** Load Carriage - leucine-enriched nutrition supplement

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Conventional Exercise with a calorie-free placebo

**Intervention Names:**

- Other: Placebo

**Label:** Conventional Exercise - Control

**Type:** PLACEBO_COMPARATOR

#### Arm Group 4

**Description:** Conventional Exercise with leucine-enriched Amino Acid supplementation

**Intervention Names:**

- Other: Leucine-enriched nutritional supplement

**Label:** Conventional Exercise - Leucine-enriched Nutrition Supplement

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Conventional Exercise - Leucine-enriched Nutrition Supplement

- Load Carriage - leucine-enriched nutrition supplement

**Description:** A protein and carbohydrate supplement with high levels of leucine

**Name:** Leucine-enriched nutritional supplement

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Conventional Exercise - Control

- Load Carriage - Control

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Change in muscle protein synthesis and whole-body protein turnover during and after load carriage or conventional exercise with or without amino acid supplementation

**Time Frame:** 90 min exercise bout (exercise) and 180 min of recovery

#### Secondary Outcomes

**Measure:** Changes in muscle performance in recovery from load carriage or conventional exercise with or without amino acid supplementation

**Time Frame:** 4, 24, 48, and 72 hours post exercise

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Weight stable (±5 lbs)with a body mass index between 22-29 kg/m2 and a VO2peak of 40 - 60 ml/kg/min
* Willing to refrain from taking any NSAIDS (i.e., aspirin, Advil®, Aleve®, Naprosyn®), or any aspirin-containing products, alchohol, and nicotine
* Females must be on oral contraception

Exclusion Criteria:

* Metabolic or cardiovascular abnormalities, gastrointestinal disorders
* Disease or medication that affects macronutrient metabolism or the ability to participate in strenuous exercise
* Allergies or intolerance to foods (e.g. lactose intolerance/milk allergy), vegetarian practices, or medications (including, but not limited to, lidocaine or phenylalanine) to be used in the study
* Anemia (HCT \<38) and Sickle Cell Anemia/Trait, abnormal PT/PTT test or problems with blood clotting
* Present condition of alcoholism, use of nutritional/sports supplements, anabolic steroids, or other substance abuse issues
* Musculoskeletal injuries that compromise the ability to exercise
* Blood donation within 8 weeks of enrollment
* Pregnancy and women not on oral contraceptives

**Healthy Volunteers:** True

**Maximum Age:** 39 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Natick

**Country:** United States

**Facility:** US Army Research Institute of Environmental Medicine

**State:** Massachusetts

**Zip:** 01760

#### Overall Officials

**Official 1:**

**Affiliation:** United States Army Research Institute of Environmental Medicine

**Name:** Stefan M Pasiakos, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Margolis LM, McClung HL, Murphy NE, Carrigan CT, Pasiakos SM. Skeletal Muscle myomiR Are Differentially Expressed by Endurance Exercise Mode and Combined Essential Amino Acid and Carbohydrate Supplementation. Front Physiol. 2017 Mar 23;8:182. doi: 10.3389/fphys.2017.00182. eCollection 2017.

**PMID:** 28386239

**Citation:** Pasiakos SM, McClung HL, Margolis LM, Murphy NE, Lin GG, Hydren JR, Young AJ. Human Muscle Protein Synthetic Responses during Weight-Bearing and Non-Weight-Bearing Exercise: A Comparative Study of Exercise Modes and Recovery Nutrition. PLoS One. 2015 Oct 16;10(10):e0140863. doi: 10.1371/journal.pone.0140863. eCollection 2015.

**PMID:** 26474292

**Citation:** Margolis LM, Murphy NE, Carrigan CT, McClung HL, Pasiakos SM. Ingesting a Combined Carbohydrate and Essential Amino Acid Supplement Compared to a Non-Nutritive Placebo Blunts Mitochondrial Biogenesis-Related Gene Expression after Aerobic Exercise. Curr Dev Nutr. 2017 May 23;1(6):e000893. doi: 10.3945/cdn.117.000893. eCollection 2017 Jun.

**PMID:** 29955707

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: AA

- Name: Amino Acids

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T10

- Name: Leucine

- Relevance: HIGH

- As Found: Cleared by

### Misc Info Module

- Version Holder: 2024-05-24
