Fluid Loading Countermeasures

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

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

• National Aeronautics and Space Administration (NASA)

  lead FED

Principal Investigators

• Jason R. Lytle, PhD · National Aeronautics and Space Administration (NASA)

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

25 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-04-01

Primary Completion

2024-10-31

Completion

2024-10-31

Countries

• United States

Study Locations