NCT06414291

Brief Summary

It is well established that rehydration with a carbohydrate-electrolyte solution is more effective in comparison to plain water. This is primarily based on the sodium-glucose co transporter, based on which the world health organization has based its oral rehydration solution recommendations. Also, rehydration with a solution that includes sodium and glucose plasma osmolality should not drop as much as it happens during rehydration with water. As a result, we should have higher fluid intake due to higher thirst perception and lower urinary output due to higher levels of vasopressin. The present study aims to examine the effectiveness of a electrolyte-glucose drink on rehydration following exercise-induced dehydration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

May 21, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2024

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

May 7, 2024

Last Update Submit

August 22, 2025

Conditions

Outcome Measures

Primary Outcomes (10)

  • Total fluid intake

    Total amount of fluid ingested

    4 hours of rehydration

  • Net fluid balance

    amount of water retained during the rehydration period

    at 4 hours of the rehydration period

  • Net fluid balance

    amount of water retained during the rehydration period

    at 3 hours of the rehydration period

  • Rate of absorption

    The rate of Deuterium appearance in the blood during 30 minutes of rehydration

    during the first 30 minutes of rehydration

  • Rate of absorption

    The rate of Deuterium appearance in the blood during 60 minutes of rehydration

    during the first 60 minutes of rehydration

  • Rate of absorption

    The rate of Deuterium appearance in the blood during 120 minutes of rehydration

    during the first 120 minutes of rehydration

  • Rate of absorption

    The rate of Deuterium appearance in the blood during 180 minutes of rehydration

    during the first 180 minutes of rehydration

  • Rate of absorption

    The rate of Deuterium appearance in the blood during 240 minutes of rehydration

    during the first 240 minutes of rehydration

  • Cumulative urine output

    Total amount of urine output during rehydration

    during the first 3 hours of rehydration

  • Cumulative urine output

    Total amount of urine output during rehydration

    during the first 4 hours of rehydration

Secondary Outcomes (7)

  • Plasma copeptin

    at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period

  • Plasma volume

    at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period

  • Free water Clearance

    at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period

  • Free Osmotic Clearance

    at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period

  • Thirst

    at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period

  • +2 more secondary outcomes

Study Arms (3)

Water

PLACEBO COMPARATOR

Rehydration with low mineral content bottle water

Other: Plain Water

Carbohydrate Electrolyte solution

EXPERIMENTAL

Drink with 22 grams of carbohydrate, 1020 milligrams of sodium, and 760 milligrams of potassium per liter. Hydration multiplier liquid IV

Other: Liquid IV Hydration Multiplier

Low Sugar electrolyte solution

EXPERIMENTAL

10 grams of carbohydrate, 1060 milligrams of sodium, and 760 milligrams of potassium per liter. Sugar free Liquid IV

Other: Liquid IV Sugar Free

Interventions

Plain water without calories, sweetener, or electolytes

Water

Drink with 22 grams of carbohydrate, 1020 milligrams of sodium, and 760 milligrams of potassium per liter. Hydration multiplier liquid IV

Carbohydrate Electrolyte solution

10 grams of carbohydrate, 1060 milligrams of sodium, and 760 milligrams of potassium per liter. Sugar free Liquid IV

Low Sugar electrolyte solution

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60 years
  • Training at least 2 times per week
  • stable weight for the last 2 months (fluctuation less than 5 pounds)

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 over 110 pounds

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

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
non labeled bottles
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Assistant Dean

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 16, 2024

Study Start

May 21, 2024

Primary Completion

December 2, 2024

Study Completion

December 3, 2024

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations