NCT05510791

Brief Summary

The study will examine the impact of the Nuun Sport tablets, as compared to water only, on heart rate, perceived exertion, and related outcomes in male and female runners, during and following the performance of a 60-minute treadmill run.

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 Jan 2022

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

December 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 19, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

December 8, 2021

Last Update Submit

August 19, 2022

Conditions

Hydration

Keywords

ElectrolyteRunningNuun

Outcome Measures

Primary Outcomes (23)

  • Heart rate

    Heart rate will be measured before and every 10 minutes during the run using a chest strap

    baseline

  • Heart rate

    Heart rate will be measured before and every 10 minutes during the run using a chest strap

    10 minutes into run

  • Heart rate

    Heart rate will be measured before and every 10 minutes during the run using a chest strap

    20 minutes into run

  • Heart rate

    Heart rate will be measured before and every 10 minutes during the run using a chest strap

    30 minutes into run

  • Heart rate

    Heart rate will be measured before and every 10 minutes during the run using a chest strap

    40 minutes into run

  • Heart rate

    Heart rate will be measured before and every 10 minutes during the run using a chest strap

    50 minutes into run

  • Heart rate

    Heart rate will be measured before and every 10 minutes during the run using a chest strap

    60 minutes into run

  • Perceived exertion

    Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)

    baseline

  • Perceived exertion

    Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)

    10 minutes into run

  • Perceived exertion

    Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)

    20 minutes into run

  • Perceived exertion

    Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)

    30 minutes into run

  • Perceived exertion

    Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)

    40 minutes into run

  • Perceived exertion

    Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)

    50 minutes into run

  • Perceived exertion

    Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)

    60 minutes into run

  • Specific gravity of urine

    Specific gravity will be determined from a urine sample

    baseline

  • Specific gravity of urine

    Specific gravity will be determined from a urine sample

    15 minutes after run

  • Plasma Volume

    Plasma Volume will be determine via blood sampling and determination of hematocrit and hemoglobin

    baseline

  • Plasma Volume

    Plasma Volume will be determine via blood sampling and determination of hematocrit and hemoglobin

    5 minutes after run

  • Body Mass

    Body Mass will be measured

    baseline

  • Body Mass

    Body Mass will be measured

    5 minutes after run

  • Body Mass

    Body Mass will be measured

    15 minutes post-run after urine collection

  • Urine output (mass)

    Urine mass will be determine following collection

    15 minutes post-run

  • Urine output (volume)

    Urine volume will be determine following collection

    15 minutes post-run

Study Arms (2)

Nuun Sport

EXPERIMENTAL

Citric Acid, Dextrose, Sodium Carbonate, Potassium Bicarbonate, Sodium Bicarbonate, Natural Flavors, Potassium Chloride, Magnesium Oxide, Calcium Carbonate, Stevia Leaf Extract, Avocado Oil, Riboflavin (for color).

Dietary Supplement: Nuun Sport Drink

Control

SHAM COMPARATOR

Water

Dietary Supplement: Control

Interventions

Nuun Sport DrinkDIETARY_SUPPLEMENT

Subjects will consume a total of 24 ounces water and 1.5 tablets of Nuun SPORT. Specifically, subjects will drink 12 ounces of Nuun drink 15 minutes prior to the 60 min run and 4 ounces of Nuun drink at 15 min, 30 min, and 45 min during the run.

Nuun Sport
ControlDIETARY_SUPPLEMENT

Subjects will consume a total of 24 ounces water. Specifically, subjects will drink 12 ounces of water 15 minutes prior to the 60 min run and 4 ounces of water at 15 min, 30 min, and 45 min during the run.

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • body mass index (BMI) between 18-29.9 kg/m2 (not obese)
  • be able to fast overnight (\>8 hrs)
  • consuming a minimum of two liters of water per day, on a regular basis
  • distance runners: run ≥ 15 miles/week, ≥ 3 runs/week, for at least the past 6 months
  • have completed a run of 60 minutes or more at least once per month for the past 6 months
  • normal resting blood pressure (systolic \< 140 mmHg, diastolic \< 90 mmHg) and heart rate (40-80bpm)
  • a negative verbal pre-study drug screen (alcohol abuse, amphetamines, benzodiazepines, cocaine, opioids, phencyclidine, barbiturates, cotinine) and no history of use of illicit drugs or other substances of abuse within 12 months of the screening visit

You may not qualify if:

  • tobacco user
  • if female, pregnant
  • history of known cardiovascular disease
  • more than 400mg caffeine intake per day
  • self-reported active infection or illness of any kind
  • consumption of alcohol-containing beverages within 48 hours of testing
  • consumption of caffeine-containing beverages within 48 hours of testing
  • strenuous exercise within 48 hours of testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

Location

Study Officials

  • Richard Bloomer, PhD

    University of Memphis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: randomized, cross-over trial with water control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean of the College of Health Sciences

Study Record Dates

First Submitted

December 8, 2021

First Posted

August 22, 2022

Study Start

January 19, 2022

Primary Completion

May 10, 2022

Study Completion

May 10, 2022

Last Updated

August 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)