Impact of Nuun Electrolyte Tablets on Hydration Status in Active Men and Women

NCT04422158 | Completed

• 1 other identifier: PRO-FY2020-327
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the impact of Nuun electrolyte tablets 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 beverage hydration index (the relative amount of urine passed after consumption of a drink compared to water). It is hypothesized that Nuun electrolyte tablets will result in a greater hydration status as compared to water only. Due to the fact that athletes use Nuun tablets at varying dosages, we will evaluate Nuun at both a single dosage and a double dosage. We maintain a non-directional hypothesis regarding the potential differences between the two different dosages tested.

Conditions

Hydration

Keywords

electrolyte

Outcome Measures

Primary Outcomes (22)

• Body weight

  Body weight will be measured

  baseline

• Body weight

  Body weight will be measured

  4 hours after drink consumption

• Urine volume

  Volume of urine output will be measured

  Immediately after completing 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 a scale

  Immediately after completing intervention

• Urine mass

  Urine output will be measured using a scale

  1 hour after intervention

• Urine mass

  Urine output will be measured using a scale

  2 hours after intervention

• Urine mass

  Urine output will be measured using a scale

  3 hours after intervention

• Urine mass

  Urine output will be measured using a scale

  4 hours after intervention

• Blood Pressure

  Blood pressure will be measured.

  at 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

  baseline

• 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

Study Arms (3)

Nuun Single strength

EXPERIMENTAL

3 Nuun electrolyte tablets will be dissolved in 1.4 liters of water. Subjects will drink one liter of the prepared solution over 30 min (250 mL every 7.5 min)

Dietary Supplement: Nuun electrolyte tablet; Other: water

Nuun Double strength

EXPERIMENTAL

6 Nuun electrolyte tablets will be dissolved in 1.4 liters of water. Subjects will drink one liter of the prepared solution over 30 min (250 mL every 7.5 min)

Dietary Supplement: Nuun electrolyte tablet; Other: water

Control

PLACEBO COMPARATOR

Subjects will drink one liter of water over 30 min (250 mL every 7.5 min)

Other: water

Interventions

Nuun electrolyte tablet DIETARY_SUPPLEMENT

Each table contains 2 grams of carbohydrate and a combination of electrolytes. calcium (13mg, 1%DV), sodium (300mg, 13%DV), potassium (150mg, 3%DV), magnesium (25mg, 6%DV), and chloride (40mg, 2%DV).

Nuun Double strength; Nuun Single strength

water OTHER

water

Control; Nuun Double strength; Nuun Single strength

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI between 18.5 and 29.9 kg/m2 (not obese)
• Consumes 2 liters of water daily
• Exercised 3 hours/week over the past 6 months

You may not qualify if:

• Obese
• Pregnant or trying to become pregnant
• Tobacco user
• Cardiac Disease
• Consumed alcohol within 48 hours of testing visit
• Consumed caffeine within 48 hours of testing visit
• Strenuous excercise 24 hours prior to testing visit

Sponsors & Collaborators

• University of Memphis: lead
• Nuun & Company, Inc (Nuun): collaborator

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen 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
• Masking Details: Drinks will be prepared without subjects aware of which drink they are receiving.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of School of Health Studies

Model Details: Randomized, single-blind, placebo-controlled, cross-over with non-directional hypothesis regarding the potential differences between the two different dosages tested.

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: June 3, 2020
• Primary Completion: August 18, 2020
• Study Completion: August 18, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)