NCT06415409

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

August 23, 2023

Last Update Submit

May 14, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Net Fluid Balance

    Net fluid balance based on body weight changes during the 4 h of the rehydration period

    3 hours of rehydration

  • Net Fluid Balance

    Net fluid balance based on body weight changes during the 4 h of the rehydration period

    4 hours of rehydration

  • Urine volume

    cumulative Urine output during the rehydration period

    3 hours of rehydration

  • Urine osmotic excretion

    Urine osmotic excretion during rehydration

    3 hours of rehydration

  • Urine osmotic excretion

    Urine osmotic excretion during rehydration

    4 hours of rehydration

Secondary Outcomes (4)

  • Stomach fullness

    3 hours of rehydration

  • Stomach fullness

    4 hours of rehydration

  • Thirst

    3 hours of rehydration

  • Thirst

    4 hours of rehydration

Study Arms (4)

Water

PLACEBO COMPARATOR

rehydration with Plain water

Other: Water

Gatorade

ACTIVE COMPARATOR

rehydration with Gatorade drink

Other: Gatorade

BodyArmor

ACTIVE COMPARATOR

Rehydration with Body Armor Drink

Other: BodyArmor

GoodSport

EXPERIMENTAL

Rehydration with Good Sport drink

Other: GoodSport

Interventions

WaterOTHER

Plain water

Water

Sport Drink Gatorade

Gatorade

Sport Drink BodyArmor

BodyArmor

Sport Drink GoodSport

GoodSport

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Training \> 2x per week
  • Age 18-55 y
  • stable weight for the last 2 months (\<5 lbs. fluctuation)

You may not qualify if:

  • night shifting work
  • thyroid medication
  • bariatric surgery
  • cardiovascular disease
  • renal disease
  • hepatic disease
  • Participating in another study at the same time
  • Bodyweight \<110 lbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Interdisciplinary Science and Technology Building 8

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Dehydration

Interventions

Watergatorade

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Unidentified bottles.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized Cross over design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2023

First Posted

May 16, 2024

Study Start

May 1, 2023

Primary Completion

January 5, 2024

Study Completion

January 12, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations