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
About this trial
This is an interventional treatment trial for Dehydration Hypertonic
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.
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
NCT ID
NCT03263975
First Posted
August 23, 2017
Last Updated
April 20, 2020
Sponsor
United States Army Research Institute of Environmental Medicine
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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