Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06415409
Other study ID # FP00034719
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date January 12, 2024

Study information

Verified date May 2024
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It is well established that post-exercise rehydration with a carbohydrate-electrolyte solution is better when compared to plain water. However, most of the commercially available drinks today are high in carbohydrates and sodium with low potassium without other active ingredients. The aim of the present study is to examine the impact of a higher electrolyte sports drink compared with traditional sports drinks and water on the time course and extent of rehydration after exercise-induced dehydration


Description:

Dehydration: Based on our previous work, dehydration will be accomplished on the morning of testing via mild exercise and heat exposure to elicit a body weight loss of -2%. The subjects will perform four bouts of 25-min low-intensity exercise and 5 min rest (alternating cycling & walking) or till they reach -2% of body weight dehydration. Rehydration: Following a 20 min rest in thermo-comfortable environment a dehydrated baseline blood sample will be taken, and subject will start the rehydration protocol. The volunteers will consume one of the four drinks below in a cross over balance mode. During the first hour four equal doses will be consumed in15-min intervals at a total volume of 150% of their body weight loss. Trials/Drinks (block randomization will be used to assign individual participants to each specific trial/drink using their ID number): - Water - GoodSport® - Gatorade® - BodyArmor® Measurements: All measurements will be performed at one of the test rooms at our lab facility that boarders the room where participants can relax and wait out the end of the study day. When certain measurements need to be performed they simply move from one room to the next. Duration of taking blood and urine samples will take not more than 30-90 seconds each, bioelectrical impedance will take a bit more time to ensure the body is in a stable rested state as a result measurement will be taken in 10 minutes, finally perceptual data will take 30-60 seconds to be reported. To allow to perform all measurements study days will take up to 7 hours. Therefore, there will be a separate space available that allows for self-study or watching TV that includes a chair and table to work on and a couch to relax. Blood samples (8 per trial, maximal 12 minutes): A total of eight 10 mL blood samples will be collected on the euhydrated baseline, dehydrated baseline and at 30, 60, 90, 120, 180, and 240 min of the rehydration period. All samples will be analyzed for glucose, osmolality, total plasma protein, hematocrit, hemoglobin (for plasma volume changes), sodium, potassium, and chloride. Urine samples (6 per trial, maximal 9 minutes): Urine samples will be collected using ~900 mL cups at euhydrated baseline, dehydrated baseline and cumulative totals will be collected at 60, 120, 180, and 240 min of the rehydration period. All samples will be analyzed for urine osmolality, specific gravity, volume, sodium, and potassium. Perceptual Data (6 per trial, maximal 9 minutes): Thirst, stomach fullness, and taste, assessed via a visual analog scale


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date January 12, 2024
Est. primary completion date January 5, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Training > 2x per week - Age 18-55 y - stable weight for the last 2 months (<5 lbs. fluctuation) Exclusion Criteria: - night shifting work - thyroid medication - bariatric surgery - cardiovascular disease - renal disease - hepatic disease - Participating in another study at the same time - Bodyweight <110 lbs.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Water
Plain water
Gatorade
Sport Drink Gatorade
BodyArmor
Sport Drink BodyArmor
GoodSport
Sport Drink GoodSport

Locations

Country Name City State
United States Interdisciplinary Science and Technology Building 8 Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Net Fluid Balance Net fluid balance based on body weight changes during the 4 h of the rehydration period 3 hours of rehydration
Primary Net Fluid Balance Net fluid balance based on body weight changes during the 4 h of the rehydration period 4 hours of rehydration
Primary Urine volume cumulative Urine output during the rehydration period 3 hours of rehydration
Primary Urine osmotic excretion Urine osmotic excretion during rehydration 3 hours of rehydration
Primary Urine osmotic excretion Urine osmotic excretion during rehydration 4 hours of rehydration
Secondary Stomach fullness Assessed via a Visual Analog scale during rehydration 3 hours of rehydration
Secondary Stomach fullness Assessed via a Visual Analog scale during rehydration. Scale is from 0-125mm with higher number indicating greater perception 4 hours of rehydration
Secondary Thirst Assessed via a Visual Analog scale during rehydration. Scale is from 0-125mm with higher number indicating greater perception 3 hours of rehydration
Secondary Thirst Assessed via a Visual Analog scale during rehydration. Scale is from 0-125mm with higher number indicating greater perception 4 hours of rehydration
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04079543 - NPO and Patient Satisfaction in the Cath Lab N/A
Recruiting NCT06063655 - Effects of Two Novel Hydration Beverage Formulas on Rehydration in Adults N/A
Completed NCT05111392 - Hydration Dynamics and Influence of Beverage Composition Phase 1/Phase 2
Terminated NCT02486224 - Metabolomic Analysis of the Impacts of Hydration Status on Exercise Performance N/A
Recruiting NCT02249845 - Comparing the Diagnostic Accuracy of Clinical Dehydration Scales Among Small Children N/A
Completed NCT01285713 - IV Glucose for Dehydration Treatment Phase 2
Withdrawn NCT00691275 - Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration N/A
Completed NCT00360204 - Improving Health Outcomes for New Mothers and Babies Phase 3
Completed NCT00370968 - Zinc-ORS in Severe and Complicated Acute Diarrhea Phase 2/Phase 3
Completed NCT04076995 - INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers N/A
Recruiting NCT05768789 - Buoy Electrolyte Study on Hydration Status of Active Men and Women N/A
Not yet recruiting NCT05428228 - Clinical Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults N/A
Completed NCT04997031 - Tap Water Intake and Perceptions in US Latinx Adults
Completed NCT04536324 - The Absorption Rate of Subcutaneous Infused Fluid
Completed NCT02926989 - Intravenous Fluids in Hospitalised Children Phase 4
Completed NCT04874584 - Culturally Tailored Nurse Coaching Study for Cancer Symptom Management N/A
Completed NCT02265575 - Hylenex-Assisted Resuscitation in Kenya (HARK) Trial for the Management of Dehydration Phase 2
Completed NCT02206581 - Using Hydration Monitor to Detect Changes in the Hydration Status Athletes N/A
Completed NCT01893853 - Fluid Balance During Exercise in the Heat With Water, Flavored Placebo, or a Carbohydrate-electrolyte Beverage Intake (The APEX Study) N/A
Completed NCT01503996 - Drinking Habits of Glaucoma Patients and Age Matched Controls N/A