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Effects of Dehydration on Neuromuscular Performance and Sympathetic Control of Cardiovascular Function

Primary Purpose

Dehydration Hypertonic, Isotonic Dehydration

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gatorade or Enterade
Sponsored by
United States Army Research Institute of Environmental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dehydration Hypertonic

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Exercise heat STress (EHS)

    Lasix (LAS)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Water and electrolyte retention
    Mass balance measures of total body water and electrolytes

    Secondary Outcome Measures

    Body water compartment changes
    Osmometric measurements and calculations of body fluid spaces

    Full Information

    First Posted
    August 23, 2017
    Last Updated
    April 20, 2020
    Sponsor
    United States Army Research Institute of Environmental Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03263975
    Brief Title
    Effects of Dehydration on Neuromuscular Performance and Sympathetic Control of Cardiovascular Function
    Official Title
    Effects of Dehydration on Neuromuscular Performance and Sympathetic Control of Cardiovascular Function
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 31, 2014 (Actual)
    Primary Completion Date
    December 8, 2016 (Actual)
    Study Completion Date
    December 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    United States Army Research Institute of Environmental Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Study Objectives and Hypotheses Primary Objective The primary objectives of this study are to understand the in vivo effects of dehydration on: Sympathetic neural control of cardiovascular function (MSNA), and Neuromuscular function (CAC) via the IT Test The primary hypotheses of this study are: Baseline MSNA, and MSNA responses to tilt, will be higher in response to extracellular dehydration due to larger intravascular volume losses and greater baroreceptor unloading. Neuromuscular function (CAC) via the IT Test will a) be more impaired by intracellular dehydration (cell stress) and b) CAC will show a greater performance reduction than CAR because it reduces the emphasis placed on the voluntary portion of performance (i.e., MVC). Ancillary Questions/Sub Studies The collection of blood and urine before and after exercise-heat stress and dehydration provides an opportunity to measure and characterize cytokine and intestinal barrier integrity marker (I-FAB, claudin-3) responses (blood) and renal stress biomarkers (urine) in humans. This descriptive research 'sub-study' directly complements Task Area T10 (Hot Weather Operations and Hydration: Injury and Performance Optimization) near and mid-term research goals of identifying biomarkers of heat stress for protection against heat injury. There are no hypotheses associated with this sub-study. The study of dehydration requires rehydration for recovery. Rehydration provides an opportunity for a novel comparison of renal water retention (urine volume) when consuming equal volumes of two different commercial beverages (Gatorade® or Enterade-S®). Unlike Gatorade®, which is a carbohydrate-based beverage containing electrolytes, Enterade-S® is an amino acid-based beverage containing electrolytes. We hypothesize that the unique formulation of Enterade-S® will improve the rate of fluid absorption and fluid retention compared to Gatorade® in both intracellular and extracellular dehydration trials.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dehydration Hypertonic, Isotonic Dehydration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Between groups design
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise heat STress (EHS)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Lasix (LAS)
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Gatorade or Enterade
    Intervention Description
    Commercially available oral rehydration therapies
    Primary Outcome Measure Information:
    Title
    Water and electrolyte retention
    Description
    Mass balance measures of total body water and electrolytes
    Time Frame
    180 minutes
    Secondary Outcome Measure Information:
    Title
    Body water compartment changes
    Description
    Osmometric measurements and calculations of body fluid spaces
    Time Frame
    180 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effects of Dehydration on Neuromuscular Performance and Sympathetic Control of Cardiovascular Function

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