NCT04764565

Brief Summary

While Nuun Instant is commercially available and has received positive reviews from athletes, there have been no studies to date to evaluate the impact of this product on hydration status. Therefore, the purpose of this study is to determine the impact of Nuun Instant powder and new product under development called Nuun Electrolyte on hydration status in young and active men and women. We will follow a similar approach as used by Maughan and colleagues (2016) to measure the fluid balance (the difference between the amount of water consumed and passed as urine) and beverage hydration index (the relative amount of urine passed after consumption of a drink compared to water), while also measuring plasma volume using the method of Dill and Costill (1974).

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 Feb 2021

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 18, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

February 23, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

1 month

First QC Date

February 18, 2021

Last Update Submit

April 26, 2021

Conditions

Hydration

Keywords

electrolytesport drinkbeverage hydration index

Outcome Measures

Primary Outcomes (26)

  • Body weight

    Body weight will be measured in underwear and papergown on digital scale.

    baseline

  • Body weight

    Body weight will be measured in underwear and papergown on digital scale.

    4 hours after intervention

  • Urine Volume

    Volume of urine output will be measured.

    Immediately following intervention

  • Urine Volume

    Volume of urine output will be measured.

    1 hour after intervention

  • Urine Volume

    Volume of urine output will be measured.

    2 hours after intervention

  • Urine Volume

    Volume of urine output will be measured.

    3 hours after intervention

  • Urine Volume

    Volume of urine output will be measured.

    4 hours after intervention

  • Urine Mass

    Urine output will be measured using an analytical scale.

    immediately after intervention

  • Urine Mass

    Urine output will be measured using an analytical scale.

    1 hour after intervention

  • Urine Mass

    Urine output will be measured using an analytical scale.

    2 hours after intervention

  • Urine Mass

    Urine output will be measured using an analytical scale.

    3 hours after intervention

  • Urine Mass

    Urine output will be measured using an analytical scale.

    4 hours after intervention

  • Blood Pressure

    Blood Pressure will be measured.

    baseline

  • Blood Pressure

    Blood Pressure will be measured.

    1 hour after intervention

  • Blood Pressure

    Blood Pressure will be measured.

    2 hours after intervention

  • Blood Pressure

    Blood Pressure will be measured.

    3 hours after intervention

  • Blood Pressure

    Blood Pressure will be measured.

    4 hours after intervention

  • Heart Rate

    Heart rate will be measured.

    immediately after intervention

  • Heart Rate

    Heart rate will be measured.

    1 hour after intervention

  • Heart Rate

    Heart rate will be measured.

    2 hours after intervention

  • Heart Rate

    Heart rate will be measured.

    3 hours after intervention

  • Heart Rate

    Heart rate will be measured.

    4 hours after intervention

  • Hematocrit

    Hematocrit will be measured from blood.

    baseline

  • Hematocrit

    Hematocrit will be measured from blood.

    4 hours after intervention

  • Hemoglobin

    Hemoglobin will be measured from blood.

    baseline

  • Hemoglobin

    Hemoglobin will be measured from blood.

    4 hours after intervention

Study Arms (3)

Nuun Instant

EXPERIMENTAL

2 servings of Nuun instant in 1 liter water

Dietary Supplement: Nuun InstantOther: Water

Control

PLACEBO COMPARATOR

1 liter of water

Other: Water

Nuun Electrolyte

EXPERIMENTAL

2.1 servings of Nuun Electrolyte in 1 liter water

Other: WaterDietary Supplement: Nuun Electrolyte

Interventions

Nuun InstantDIETARY_SUPPLEMENT

Contains (per 11 gram serving) the following: 7 grams of carbohydrate, calcium (20mg, 2%DV), sodium (520mg, 23%DV), potassium (385mg, 8%DV), magnesium (8mg, 2%DV), chloride (250mg, 10%DV), and 100% of vitamin C (90mg) and B12 (2.4 mcg).

Nuun Instant
WaterOTHER

water

ControlNuun ElectrolyteNuun Instant
Nuun ElectrolyteDIETARY_SUPPLEMENT

Citric Acid, Dextrose, Sodium Bicarbonate, Potassium Bicarbonate, Sodium Carbonate, Natural Flavors, Potassium Chloride, Malic Acid, Magnesium Carbonate, Calcium Carbonate, Stevia Leaf Extract, Beet Powder Color, Safflower Oil. Nuun electrolytes contains (per tablet) the following: 3 grams of carbohydrate, calcium (15 mg, 1%DV), sodium (200 mg, 9%DV), potassium (125mg, 3%DV), magnesium (15mg, 4%DV), and chloride (75mg, 3%DV).

Nuun Electrolyte

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
  • no consumption of alcohol-containing beverages within 48 hours of testing
  • no consumption of caffeine-containing beverages within 48 hours of testing
  • no strenuous exercise within 48 hours of testing
  • regularly consumes 2 liters of water daily
  • engaged in structured exercise 3 or more hours per week for the past 6 months or longer

You may not qualify if:

  • tobacco user
  • active infection or illness
  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Reseach

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Richard Bloomer, PhD

    University of Memphis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: single-blind crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean of the College of Health Sciences

Study Record Dates

First Submitted

February 18, 2021

First Posted

February 21, 2021

Study Start

February 23, 2021

Primary Completion

April 6, 2021

Study Completion

April 6, 2021

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)