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OpenTrials
Completed

NCT Number: NCT06185595

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

The objective of this study is to determine the effect of consumption of drinks with varying amounts of glycerol and electrolytes on fluid balance at rest.

Completed

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PepsiCo R&D, Gatorade Sports Science Institute

Valhalla, New York, 10595, United States

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
  • Subject is 18-50 years of age, inclusive
  • You are 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 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
  • 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

Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.

Other

9.3 oz (273 ml) aliquot of one of the study beverages every 15 min for a total of 28 oz (828 ml) over a 45-min period, followed by 15 min of rest. Flavored water matched for sweetness, color. flavor, but cannot be matched for saltiness. All sodium-containing drinks will include a base blend of other electrolytes (potassium 15 mmol/L, magnesium 8 mmol/L, and calcium 5 mmol/L).

Primary outcomes

  1. Fluid balance

    Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes

    Change in body mass to the nearest 0.005 kilogram (kg) using a platform scale

Secondary outcomes

  1. Fluid retention

    Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes

    As a percent (%)

  2. Urine mass

    Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes

    By urine mass scale in grams (g)

  3. Urine specific gravity

    Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes

    By USG digital pen refractometer

  4. Blood sodium

    Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes

    By iSTAT Blood Electrolyte and Chemistry Analyzer (CG8+ cartridge) in mmol/L

  5. Blood glucose

    Time frame: Screening visit only

    Glucometer for point of care test in mg/dL

  6. Blood glucose

    Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes

    By iSTAT Blood Electrolyte and Chemistry Analyzer (CG8+ cartridge) in mg/dL

  7. Percent change in plasma volume

    Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes

    Calculated from hematocrit and hemoglobin concentration

  8. Serum glycerol concentration

    Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes

    By Sigma Aldrich glycerol assay kit in mmol/L

  9. Blood pressure

    Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes

    mmHg by automatic sphygmomanometer

  10. Heart rate

    Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes

    Beats per minute (bpm) by heart rate monitor

  11. Subjective measures of gastrointestinal discomfort and headache

    Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes

    Visual Analog Scale (VAS) symptom rating of how you feel right now by placing a slash along a 100 millimeter (mm) vertical line anchored from 0 mm (None) to 100 mm (Severe). Fewer symptoms and lower numbers are better.

  12. Menstrual cycle phase

    Time frame: Female participants log menstrual flow throughout study participation. The three study sessions (2-45 days apart) are scheduled to avoid menses and can be completed in the same menstrual cycle, or in 3 different cycles (3 different months) if needed.

    Date of last menstrual period by self-report of female participant

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 29, 2023
Registry last updated
Jan 3, 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.

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