NCT03263975

Brief Summary

The mechanism(s) by which dehydration (both intra- and extracellular) impairs performance are still poorly described. A loss of volume results in increased occurrence of orthostatic intolerance, including dizziness, fatigue, headaches and related symptoms with upright posture. Any of these symptoms can contribute to decreased performance in maneuvers performed in the upright posture, which includes many military tasks. Thus, loss of volume challenges the cardiovascular and blood pressure responses to systemic whole body endurance exercise, while osmolality is the stimulus for intracellular dehydration that may impair local muscle force production by impairing contractile function, neural signaling, or both. In this study, we will compare how both types of dehydration affect MSNA and CAC. The results of this study will provide mechanistic insight for how dehydration (intra- or extracellular) impairs systemic whole body and local small muscle performance in vivo. This Basic Science study seeks to understand how volume and osmolality impact MSNA and CAC as a basis for improving potential countermeasures, such as a more optimally formulated rehydration beverage. Therefore, this study directly complements Task Area T10 (Hot Weather Operations and Hydration: Injury and Performance Optimization) and impacts virtually all 14 Military Operational Medicine Research Program Drivers.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

2.1 years

First QC Date

August 23, 2017

Last Update Submit

April 20, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Water and electrolyte retention

    Mass balance measures of total body water and electrolytes

    180 minutes

Secondary Outcomes (1)

  • Body water compartment changes

    180 minutes

Study Arms (2)

Exercise heat STress (EHS)

EXPERIMENTAL

EHS - dehydration produced by sweating and fluid restriction; primary loss of body water accompanied by small loss of electrolytes (hypertonicity). Interventions include rehydration with Gatorade or Enterade oral rehydration therapies.

Other: Gatorade or Enterade

Lasix (LAS)

EXPERIMENTAL

LAS - dehydration produced by Lasix (diuretic, 80 mg oral dose) administration to produce losses of body water accompanied by large losses of electrolytes (isotoncity). Interventions include rehydration with Gatorade or Enterade oral rehydration therapies.

Other: Gatorade or Enterade

Interventions

Commercially available oral rehydration therapies

Exercise heat STress (EHS)Lasix (LAS)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female, age 18-45
  • In good health as determined by OMSO General Medical Clearance
  • Passed his/her most recent Army Physical Fitness Test (APFT) (military volunteers only) or exercise at least 2 times per week (civilian volunteers)
  • Ability to comprehend and willingness to sign informed consent

You may not qualify if:

  • Females who are pregnant or planning to become pregnant during the study
  • Taking prescription or over the counter medication, other than a contraceptive (unless approved by OMSO and PI)
  • Physical problems/injuries associated with walking or cycling
  • Allergy to sulfa drugs (Lasix™ or sulfonamide antibiotics such as Septra™)
  • Allergy to skin adhesive
  • Hemoglobinopathy (sickle cell trait)
  • Heart, lung, kidney, muscle, or nerve disorder(s)
  • History of heat or orthostatic intolerance
  • Diagnosed and/or treated for fluid/electrolyte imbalance within the last 30 days
  • Presence of metal implants/electronic medical devices in lower extremities
  • Current or previous (within the past 5 years) diagnosis of any autonomic disorder, including idiopathic orthostatic intolerance, orthostatic hypotension, postural tachycardia syndrome (POTS), or neurocardiogenic syncope (MSNA group only)
  • Tobacco/nicotine use (MSNA group only)
  • Significant muscle, joint, or bone injury affecting the legs within the last 6 months (CAC group only)
  • Difficulty swallowing large pills
  • History of obstructive disease of the gastrointestinal tract including (but not limited to) diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis; or previous gastrointestinal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

gatorade

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Between groups design
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 28, 2017

Study Start

October 31, 2014

Primary Completion

December 8, 2016

Study Completion

December 1, 2017

Last Updated

April 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share