NCT06858904

Brief Summary

It is well established that post-exercise rehydration with electrolyte solutions is more effective than plain water. However, most commercially available drinks are high in electrolytes but lack some essential trace minerals. This study aims to examine the impact of a higher-electrolyte sports drink compared with a low-electrolyte, trace-mineral-rich solution 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
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

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

First Submitted

Initial submission to the registry

February 28, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

March 26, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2025

Completed
Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

February 28, 2025

Last Update Submit

September 3, 2025

Conditions

Dehydration (Physiology)

Keywords

rehydrationsports drinksfluid balancewater retention

Outcome Measures

Primary Outcomes (5)

  • Net Fluid Balance

    Body water Retention after exercise-induced dehydration

    at 60 minutes, 120 minutes, 180 minutes and 240 minutes of rehydration

  • Urine volume

    Urine volume during the rehydration period

    1, 2, 3, and 4 hour of the rehydration period

  • Free water clearance

    Free water clearance during the rehydration period

    1, 2, 3, and 4 hours of the rehydration period

  • Osmotic Clearance

    Osmotic renal clearance during the rehydration period

    1, 2, 3, and 4 hours of the rehydration period

  • Skin Hydration

    Skin hydration at the face assessed with a moisture meter.

    1, 2, 3, and 4 hours of the rehydration period

Secondary Outcomes (4)

  • Plasma Volume

    1, 2, 3, and 4 hours of the rehydration period

  • Stomach fullness

    1, 2, 3, and 4 hours of the rehydration period

  • Gastrointestinal symptoms

    At the end of the 4 hours rehydration period

  • Plasma Osmolality

    1, 2, 3, and 4 hours of the rehydration period

Study Arms (3)

ConcenTrace

EXPERIMENTAL

Beverage with ConcenTrace minerals

Dietary Supplement: ConcenTrace

ZeroLyte

EXPERIMENTAL

Beverage with high level of trace elements but no sugar

Dietary Supplement: ZeroLyte

Placebo

PLACEBO COMPARATOR

Water with non caloric, non-sodium containing sweetner

Dietary Supplement: Placebo

Interventions

PlaceboDIETARY_SUPPLEMENT

Non- calorically sweetened Water

Placebo
ConcenTraceDIETARY_SUPPLEMENT

1.25 milliliter of concentrace per liter

ConcenTrace
ZeroLyteDIETARY_SUPPLEMENT

Beverage with 1 pack of ZeroLyte per 500 milliliter of water

ZeroLyte

Eligibility Criteria

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

You may qualify if:

  • Recreationally physically active: Training \> 2x per week and ≤ 6hours per week
  • BMI of 18.5-29.9
  • Stable weight for the last 2 months (\<5 pounds. fluctuation)

You may not qualify if:

  • Women who are pregnant, breast feeding, or planning to become pregnant during the trial
  • night shifting work
  • thyroid medication
  • bariatric surgery
  • cardiovascular disease
  • renal disease
  • hepatic disease
  • Participating in another study at the same time
  • Bodyweight \<110 pounds
  • Currently Smoker
  • Major surgery, including abdominal, in the past 3 months or individuals who have planned surgery during the trial.
  • Alcohol or drug abuse within the last 12 months
  • High alcohol intake (average of \> 2 standard drinks per day or \> 10 standard drinks per week)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hydration Science Lab

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
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Assistant Dean

Study Record Dates

First Submitted

February 28, 2025

First Posted

March 5, 2025

Study Start

March 26, 2025

Primary Completion

August 29, 2025

Study Completion

August 29, 2025

Last Updated

September 5, 2025

Record last verified: 2025-09

Locations

US(1)