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

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ClinicalTrials.gov Identifier: NCT03263975
Recruitment Status : Completed
First Posted : August 28, 2017
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
United States Army Research Institute of Environmental Medicine

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.


Condition or disease Intervention/treatment Phase
Dehydration Hypertonic Isotonic Dehydration Other: Gatorade or Enterade Not Applicable

Detailed Description:

Study Objectives and Hypotheses

Primary Objective

The primary objectives of this study are to understand the in vivo effects of dehydration on:

  1. Sympathetic neural control of cardiovascular function (MSNA), and
  2. Neuromuscular function (CAC) via the IT Test

The primary hypotheses of this study are:

  1. 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.
  2. 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

  1. 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.
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Between groups design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Dehydration on Neuromuscular Performance and Sympathetic Control of Cardiovascular Function
Actual Study Start Date : October 31, 2014
Actual Primary Completion Date : December 8, 2016
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise heat STress (EHS)
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
Commercially available oral rehydration therapies

Experimental: Lasix (LAS)
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
Commercially available oral rehydration therapies




Primary Outcome Measures :
  1. Water and electrolyte retention [ Time Frame: 180 minutes ]
    Mass balance measures of total body water and electrolytes


Secondary Outcome Measures :
  1. Body water compartment changes [ Time Frame: 180 minutes ]
    Osmometric measurements and calculations of body fluid spaces



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier: NCT03263975    
Other Study ID Numbers: 14-03H
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes