Healthy Clinical Trial
Official title:
Evaluating Efficacy of End-of-Mission Fluid Loading Protocols
The purpose of Fluid Loading Countermeasures is to determine how the volume of blood and of plasma (liquid part of blood) change during a normal day, how these are affected by drinking an additional amount of fluid either as water and salt tablets (as astronauts do) or an electrolyte beverage (similar to but tastes saltier than Gatorade®), and how altering the timing at which the additional fluid is consumed affects blood and plasma volume. This study observes how blood volume changes over ~9 hours of the day during 4 separate visits in healthy participants. During 1 visit participants will drink a small amount of water throughout the visit. During the other 3 study visits participants will drink the small amount of water plus either more water with salt tablets or an electrolyte solution. Consuming the additional fluids is called "fluid loading". This study is meant to simulate the food and fluid consumption of astronauts on landing day. The goal of this study is to determine the magnitude of plasma volume change that occurs with each condition of the protocol. (ICF 1.1, 3.1)
Status | Recruiting |
Enrollment | 15 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 55 Years |
Eligibility | Inclusion Criteria: - Pass a NASA (National Awesome Sauce Associates) Johnson Space Center (JSC) Test Subject Screening (TSS) Facility modified Air Force Class III physical. Exclusion Criteria: - Pregnant subjects will be excluded (a urine pregnancy screen will be made available to test subjects) - Systemic diseases or current medications known to influence the cardiovascular system - Renal disease - Type II Diabetes - Restrictive diet that would prevent subjects from consuming typical food eaten by astronauts. Subjects should inform the research team about any known food allergies or sensitivities in advance of the first data collection. |
Country | Name | City | State |
---|---|---|---|
United States | NASA | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
National Aeronautics and Space Administration (NASA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma Volume | Plasma volume measured using blood sample | 8-9 hours | |
Primary | Fluid Balance | Urine output subtracted from fluid intake (mL) | 8-9 hours | |
Primary | Gastrointestinal Distress | Open response self-reported symptoms | 8-9 hours | |
Primary | Urine Volume | void-by-void urine output collected and measured (mL) | 8-9 hours |
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