Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06654557

Effect of Adding Glycerol to Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest

The results of a prior study PEP-2311 suggested there was a positive dose-response effect of glycerol and sodium on fluid balance and fluid retention. In addition, inclusion of glycerol resulted in an upward shift in the relationship between sodium concentration and fluid balance. The practical interpretation is that addition of glycerol enables a reduction in sodium concentration compared with a 0% glycerol drink.

In this follow-up study, the investigators hypothesize that 1) fluid balance will be sustained (greater than or not different from baseline) and significantly greater than placebo for 120 min after drinking the test no/low/moderate carbohydrate beverages and 2) fluid balance will not differ between the carbohydrate-electrolyte beverages, but both will be greater than placebo.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This is a two-part study. Subjects will be asked to complete either Part 1 or Part 2 of this study. Subjects can participate in both parts of the study if they are interested and available to complete all trials. However, they will be asked to complete Part 1 before enrolling in Part 2 of the study. Dosing days are separated by 2-15 days.

Objective 1) To compare the effect of consumption of four no/low/moderate carbohydrate drinks with high electrolyte concentrations vs. placebo on fluid balance at rest. To enroll N=25

Objective 2) To compare the effect of consumption of two moderate carbohydrate drinks with low electrolyte concentrations vs. placebo on fluid balance at rest. To enroll N=70

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject is male or female

  • If female, subject is not pregnant (based on self-report)
  • Subject is 18-50 years of age, inclusive Subject is at least recreationally active (engaged in light to moderate intensity, intermittent, or steady-state exercise at least 3 days per week for at least 30 min at a time)
  • Subject does not smoke (or has quit for at least 6 months)
  • Subject is not taking medication that may interfere with the study (e.g., diuretics)
  • Subject has no health conditions that would interfere with the study, As indicated on the general health questionnaire (GHQ), e.g. cardiovascular, renal, or metabolic diseases
  • Subject is not allergic to adhesives (e.g., medical tape)
  • Subject is not allergic to kiwi-strawberry flavoring
  • Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
  • Subject is willing to fast overnight (~8-12 hours)
  • Subject is willing to refrain from vigorous exercise for 24 hours (light physical activity only)
  • Subject is willing to eat the exact same food the day prior to each visit to the laboratory
  • Able to speak, write, and read English
  • Provision of written consent to participate

Exclusion criteria

  • Subject has participated in a clinical trial within the past 30 days
  • Subject has participated in any PepsiCo trial within past 6 months
  • Subject has a condition or is taking medication that the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the person at undue risk
  • Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If subject is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.

Treatment and study plan

Placebo beverage, kiwi-strawberry flavor (Part 1 and Part 2)

Other

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose.

0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only)

Other

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only)

Other

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)

Other

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)

Other

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)

Other

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)

Other

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

Primary outcomes

  1. Fluid balance (Body Weight)

    Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

    Platform scale to the nearest 0.005 kilograms (kg)

  2. Fluid balance (Percent (%) change in Body Mass)

    Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

    Platform scale to the nearest 0.005 kilograms (kg)

Secondary outcomes

  1. Fluid retention

    Time frame: % change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

    Platform scale to the nearest 0.005 kilograms (kg), unit percent (%)

  2. Urine mass

    Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

    Graduated cylinder on scale to the nearest 0.01 grams

  3. Urine specific gravity

    Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

    USG digital pen refractometer (Atago), no unit

  4. Blood sodium

    Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

    Fingerstick sampling, unit millimoles per liter (mmol/L), iSTAT Blood Electrolyte and Chemistry Analyzer (CHEM8+ cartridge)

  5. Blood glucose

    Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

    Fingerstick sampling, unit milligrams per deciliter (mg/dl), iSTAT Blood Electrolyte and Chemistry Analyzer (CHEM8+ cartridge)

  6. Percent change in plasma volume

    Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

    Fingerstick sampling, calculated from hematocrit and hemoglobin concentration percent (%)

  7. Serum glycerol concentration

    Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

    Fingerstick sampling unit millimoles per liter (mmol/L) using Sigma Aldrich glycerol assay kit

  8. Serum osmolality

    Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

    Fingerstick sampling, unit milliosmoles per kilogram of water (mOsm/Kg H20)

  9. Saliva osmolality

    Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

    Measured directly from the tongue using a handheld MX3 Diagnostics device, unit milliosmoles per kilogram of water (mOsm/kg H2O)

  10. Blood pressure (systolic/diastolic)

    Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

    Automatic sphygmomanometer unit millimeters of mercury (mm/Hg)

  11. Heart rate

    Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

    Heart rate monitor, unit beats per minute (bpm)

  12. Subjective measure of headache

    Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

    One item on a 100 point visual analog scale anchored from 0=No headache to 100=Severe headache

  13. Subjective measure of lightheadedness

    Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

    One item on a 100 point visual analog scale anchored from 0=No lightheadedness to 100=Severe lightheadedness

  14. Subjective measures of gastrointestinal discomfort

    Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

    Eight items on a 100 point visual analog scale (stomach upset, nausea, burping, stomach bloating, abdominal discomfort, stomach fullness, vomiting, diarrhea anchored frrom 0= None to 100=Severe

  15. Menstrual categorization

    Time frame: Assessed at Screening Visit

    Using Elliott-Sale chart, 2023 to categorize menstrual/hormonal contraceptive status for those who have not yet reached perimenopause/menopause. This is a decision-tree chart, not a scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Lindsay Baker, PhD

CONTACT

[email protected]

814-883-9454

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2024
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.