Recruiting

Fluid Loading

Sponsor:

National Aeronautics and Space Administration (NASA)

Code:

NCT06467812

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Accepted

Interventions

Salt Tablets

Electrolyte Solution

Study Details

Brief summary:

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)

Conditions

Healthy

Study ID

NCT06467812

Start date

Apr 1, 2022

Status verified date

Aug, 2023

Completion date

Oct, 2024

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control

A typical water and meal schedule will be followed on the Control day.

experimental: Water plus Salt Tablets

A typical water and meal schedule will be followed, with the addition of Fluid Loading water plus salt tablets.

experimental: Electrolyte Solution over 4 hours

A typical water and meal schedule will be followed, with the addition of Fluid Loading electrolyte solution over 4 hours.

experimental: Electrolyte Solution Single Bolus

A typical water and meal schedule will be followed, with the addition of Fluid Loading electrolyte solution single bolus.

Interventions

Salt Tablets

Three doses of 4 Salt Tablets (1gm) will be taken with 400mL of water on day 2 (1200ml total) between \~8am and \~12pm during the testing day, which runs from \~7am to \~3:30pm.

Electrolyte Solution

Three doses of 400mL of the Electrolyte Solution dissolved in water (1200 mL total) will be consumed on day 3 between \~8am and \~12pm during the testing day, which runs from \~7am to \~3:30pm. On day 4 the Electrolyte Solution Single Bolus will be consumed in a single dose of 1200mL at \~12pm during the testing day.

The ingredients are included below for the two flavors offered.

Orange flavor: Water, Dextrose with Maltodextrin, Aspartame, Acesulfame Potassium, Sodium Citrate, Salt, Citric Acid, Maltodextrin, Natural Flavor, Calcium Phosphate, Contains less than 2% Of Ascorbic Acid (Vitamin C), Artificial Flavor, Artificial Color, Red 40, Yellow 5, BHA (Butylated Hydroxyanisole).

Lemonade flavor: Water, Dextrose with Maltodextrin, Aspartame, Acesulfame Potassium, Sodium Citrate, Salt, Citric Acid, Calcium Phosphate, Maltodextrin, Contains less than 2% Of Ascorbic Acid (Vitamin C), Natural Flavor, Artificial Color, Yellow 5, BHA.

Primary outcome measure

  • Plasma Volume [ Time Frame: 8-9 hours ]
  • Fluid Balance [ Time Frame: 8-9 hours ]
  • Gastrointestinal Distress [ Time Frame: 8-9 hours ]
  • Urine Volume [ Time Frame: 8-9 hours ]

Central Contacts and Locations

Central contacts

Jason R. Lytle, PhD

805-407-5038jason.r.lytle@nasa.gov

Lucinda M. Yu, MS

lucinda.m.yu@nasa.gov

Locations

NASA

Recruiting

Houston, Texas, United States, 77058

Contacts

Jason R. Lytle, PhD

jason.r.lytle@nasa.gov

Lucinda M. Yu, MS

lucinda.m.yu@nasa.gov

More Information

Sponsor

National Aeronautics and Space Administration (NASA)

Last update posted

Jul 10, 2024

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Aeronautics and Space Administration (NASA) on 2024-07-10.