Dehydration HypertonicNCT03263975
Effects of Dehydration on Neuromuscular Performance and Sympathetic Control of Cardiovascular Function
A study testing Gatorade or Enterade in people with Dehydration Hypertonic and Isotonic Dehydration, run by United States Army Research Institute of Environmental Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration Hypertonic, Isotonic Dehydration
- What is being tested?
- Gatorade or Enterade
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2014to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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.
About this study
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.
Read the 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.
- Conditions
- Dehydration Hypertonic, Isotonic Dehydration
- Being tested
- Gatorade or Enterade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gatorade or EnteradeOther
Commercially available oral rehydration therapies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Gatorade or Enterade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Water and electrolyte retention
Mass balance measures of total body water and electrolytes
Measured: 180 minutes
Secondary outcomes (1)
Body water compartment changes
Osmometric measurements and calculations of body fluid spaces
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start31 Oct 2014
- Primary completion8 Dec 2016
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dehydration HypertonicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Between groups design
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263975
- Sponsor's protocol ID
- 14-03H
- Status last verified
- Apr 2020
- First submitted
- 23 Aug 2017
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dehydration on Neuromuscular Performance and Sympathetic Control of Cardiovascular Function
- ClinicalTrials.gov ID
- NCT03263975
- Acronym / sponsor ID
- 14-03H
- Conditions
- Dehydration Hypertonic, Isotonic Dehydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- 31 Oct 2014 (actual)
- Primary completion
- 8 Dec 2016 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Between groups design
| Arm | Type | Receives |
|---|---|---|
| Exercise heat STress (EHS) | Experimental | Other: Gatorade or EnteradeEHS - 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. |
| Lasix (LAS) | Experimental | Other: Gatorade or EnteradeLAS - 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gatorade or EnteradeCommercially available oral rehydration therapies | Other | Exercise heat STress (EHS), Lasix (LAS) |
Primary outcome
Water and electrolyte retention
Time frame: 180 minutes
Mass balance measures of total body water and electrolytes
1 secondary outcome
Body water compartment changes
Time frame: 180 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Gatorade or Enterade in people with Dehydration Hypertonic and Isotonic Dehydration, run by United States Army Research Institute of Environmental Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Water and electrolyte retention (time frame: 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.