NCT07658820

Brief Summary

The aim of the present study is to evaluate the effectiveness of a milk permeate-based sports drink on hydration, carbohydrate oxidation, exercise performance, vigilance, and reaction time in the heat. We anticipate that the milk permeate, with 44 g per liter and high sodium and potassium, will lead to better hydration, energy delivery, and physical and cognitive performance.

Trial Health

63
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Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress7%
Jun 2026Dec 2027

First Submitted

Initial submission to the registry

June 10, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 22, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

June 10, 2026

Last Update Submit

June 17, 2026

Conditions

HydrationDehydration (Physiology)Performance

Keywords

exercise in the heatcognitive performance

Outcome Measures

Primary Outcomes (2)

  • Time to completion of 5 kilometer cycling time trial

    cycling performance expressed as time to completion.

    Five minutes after completion of the two-hour cycling protocol

  • Psycho-motor Vigilance test

    Psycho-motor Vigilance test measured by reaction time in milliseconds

    Five minutes after completion of the 5-kilometer cycling test

Secondary Outcomes (2)

  • Plasma Osmolality

    Plasma osmolality at 0, 30, 60, 90, and 120 minutes of the 2-hour steady cycling, at the end of the 5-kilometer cycling time trial, and within 2 minutes after the cognitive test.

  • Carbohydrate oxidation rate during exercise

    At minutes 15, 60, and 120 of the 2-h steady-state cycling exercise

Study Arms (4)

Placebo

PLACEBO COMPARATOR

no caloric, no sodium containing flavor water

Dietary Supplement: Water (Placebo)

Carbohydrate Milk Permeate sports drink

EXPERIMENTAL

GoodSport sports drink

Dietary Supplement: Carbohydrate Milk Permeate sports drink

Traditional Sports drink with 6% carbs

EXPERIMENTAL

Gatorade sports drink

Dietary Supplement: 6% Sports drink

Low Carbohydrate Milk Permeate sports drink

EXPERIMENTAL

LowCarb GoodSport sports drink

Dietary Supplement: Low-Carbohydrate Milk Permeate sports drink

Interventions

Water (Placebo)DIETARY_SUPPLEMENT

Flavor water

Placebo
Carbohydrate Milk Permeate sports drinkDIETARY_SUPPLEMENT

4.4% carbohydrate sports drink

Carbohydrate Milk Permeate sports drink
6% Sports drinkDIETARY_SUPPLEMENT

Gatorade with 6% carbohydrate content

Traditional Sports drink with 6% carbs
Low-Carbohydrate Milk Permeate sports drinkDIETARY_SUPPLEMENT

2.2% Carbohydrate Milk Permeate sports drink

Low Carbohydrate Milk Permeate sports drink

Eligibility Criteria

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

You may qualify if:

  • Healthy and injury free (muscle, skeletal) for greater than 2 months
  • Active cyclists who train at least 3 times per week
  • Body mass index (BMI) range of 18.5-30 kg/m2
  • VO₂max ≥ 51 mL/kg/min for male participants
  • VO₂max ≥ 45 mL/kg/min for female participants

You may not qualify if:

  • Taking medicine influences the cardiovascular system
  • non-steroidal anti-inflammatory drugs during the last week
  • Cancer Diagnosis during the last 5 years
  • Current Pregnancy
  • History of renal disease, hypertension, obstructive gastrointestinal tract disease, disorders or impairment of the gag reflex, previous gastrointestinal surgery
  • History of heat stroke
  • Use of testosterone therapy
  • Adults who are unable to consent (impaired decision-making capacity)
  • Adults having Felinization of the esophagus
  • Adults who will undergo Nuclear Magnetic Resonance (NMR) or MRI scanning within 3 days of swallowing a temperature sensitive pills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

850 Phoenix Bioscience Core

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Dehydration

Interventions

Water

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Central Study Contacts

Sajjad Rezaei, MS

CONTACT

515-441-4904srezaei8@asu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 22, 2026

Study Start

June 22, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)