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Search / Trial NCT06854471

Effects of Beverage Volume, Glycerol Concentration, and Sodium Concentration on Fluid Balance in Healthy Euhydrated Men and Women at Rest

Launched by PEPSICO GLOBAL R&D · Feb 28, 2025

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Hydration Electrolytes Glycerol Beverage

ClinConnect Summary

This clinical trial is studying how different amounts of sodium and glycerol in drinks can affect how well our bodies retain fluids. When we drink fluids, we want our bodies to keep them instead of losing them through urination. The researchers are looking at how varying the concentration of these ingredients, along with the amount of fluid consumed, impacts fluid balance in healthy men and women.

To participate in this study, you need to be between 18 and 50 years old, be physically active (exercising at least three days a week), and not be pregnant if you are female. You should also be a non-smoker and not taking medications that could interfere with the study. Participants will be asked to avoid alcohol for 24 hours before visits, fast overnight, and eat the same food the day before each lab visit. If you join, you will help researchers better understand how our bodies manage fluid intake, which can be important for health and hydration.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Subject is male or female
  • If female, subject is not pregnant
  • 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 (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
  • 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.

About Pepsico Global R&D

PepsiCo Global R&D is a leading innovator in the food and beverage industry, dedicated to advancing the science of nutrition and product development. With a strong focus on health and wellness, the organization conducts rigorous clinical trials to explore the efficacy and safety of its products, aiming to enhance consumer experiences while promoting sustainable practices. Leveraging cutting-edge research methodologies and a multidisciplinary approach, PepsiCo Global R&D collaborates with academic institutions and healthcare professionals to drive evidence-based advancements in nutrition, ensuring that its offerings meet the evolving needs of consumers worldwide.

Locations

Saint Petersburg, Florida, United States

Patients applied

0 patients applied

Trial Officials

Lawrence Galitz, MD

Principal Investigator

GCP Research

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported