95 Participants Needed

Glycerol-Enhanced Electrolyte Beverages for Fluid Balance

LB
Overseen ByLindsay Baker, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: PepsiCo Global R&D
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different electrolyte drinks to determine their effectiveness in maintaining fluid balance. Researchers aim to discover if adding glycerol, a specific compound, enhances hydration compared to regular drinks without it. Participants will try various drinks, some containing glycerol and some not, to compare their effects on hydration over time. The trial seeks individuals who are active at least three days a week and do not have major health issues that could interfere with the study. As an unphased trial, it offers participants the chance to contribute to innovative research on hydration solutions.

Will I have to stop taking my current medications?

The trial requires that you do not take medications that may interfere with the study, such as diuretics (medications that help remove excess water from the body). If you are taking any medication, it's best to discuss it with the study investigator to see if it might affect your participation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that glycerol is safe for humans. Research indicates that when glycerol is used in drinks with electrolytes, it effectively manages body fluids without causing major side effects. For example, one study found that glycerol improved fluid retention, which is important for proper hydration.

Another study found that even at higher amounts, glycerol did not cause serious health problems. Some participants experienced minor issues like mild stomach discomfort, but these were rare and typically resolved on their own.

Overall, research suggests that glycerol in these drinks is generally safe for healthy people, with a low risk of negative side effects.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these glycerol-enhanced electrolyte beverages because they offer a new way to improve fluid balance. Unlike typical electrolyte solutions, these beverages include glycerol, which can enhance water absorption and retention in the body. This could be especially beneficial for athletes or individuals needing to maintain hydration during intense physical activity. By altering the carbohydrate and glycerol content, the solutions could potentially optimize performance and recovery in ways current sports drinks do not.

What evidence suggests that this trial's treatments could be effective for fluid balance?

This trial will compare various electrolyte beverages, both with and without glycerol, to assess their effectiveness in maintaining hydration. Studies have shown that adding glycerol to electrolyte drinks can enhance hydration compared to similar drinks without it. Research indicates that glycerol enables these drinks to maintain hydration effectively, even with reduced sodium. Tests with drinks containing 0%, 1%, and 6% carbohydrates plus glycerol showed they kept people better hydrated than drinks without glycerol. This suggests glycerol may help the body retain fluids more effectively, offering promise for improved hydration.12356

Who Is on the Research Team?

LB

Lindsay Baker, PhD

Principal Investigator

PepsiCo R&D Life Sciences, Sports Science

Are You a Good Fit for This Trial?

This trial is for healthy men and women who are well-hydrated (euhydrated) and at rest. Specific details about age, health conditions, or other criteria aren't provided here.

Inclusion Criteria

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)
I am either male or female.
I am not pregnant.
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Exclusion Criteria

Subject has participated in a clinical trial within the past 30 days
Subject has participated in any PepsiCo trial within the 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
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Part 1 Treatment

Participants consume no/low/moderate carbohydrate drinks with high electrolyte concentrations or placebo to assess fluid balance at rest

1 day per dosing session, with 2-15 days between sessions
Multiple visits (in-person)

Part 2 Treatment

Participants consume moderate carbohydrate drinks with low electrolyte concentrations or placebo to assess fluid balance at rest

1 day per dosing session, with 2-15 days between sessions
Multiple visits (in-person)

Follow-up

Participants are monitored for changes in fluid balance, blood sodium, and other secondary measures after treatment

1-2 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Glycerol
Trial Overview The study tests if drinks with glycerol improve fluid balance better than a placebo drink that looks and tastes similar but doesn't have glycerol. Participants will try no/low/moderate carbohydrate beverages to see how they affect hydration over two hours.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Placebo Group
Group I: 6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)Experimental Treatment1 Intervention
Group II: 6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)Experimental Treatment1 Intervention
Group III: 2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)Experimental Treatment1 Intervention
Group IV: 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)Experimental Treatment1 Intervention
Group V: 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only)Experimental Treatment1 Intervention
Group VI: 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only)Experimental Treatment1 Intervention
Group VII: Placebo beverage (Parts 1 and 2)Placebo Group1 Intervention

Glycerol is already approved in United States, European Union for the following indications:

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Approved in United States as Glycerol for:
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Approved in European Union as Glycerol for:

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Who Is Running the Clinical Trial?

PepsiCo Global R&D

Lead Sponsor

Trials
99
Recruited
13,600+

Ramon Laguarta

PepsiCo Global R&D

Chief Executive Officer since 2018

MBA from ESADE Business School

Mark Kirkham

PepsiCo Global R&D

Chief Marketing Officer

Bachelor's degree in Business Administration from Trinity College Dublin

Published Research Related to This Trial

Glycerol-induced hyperhydration (GIH) significantly improves fluid retention compared to water-induced hyperhydration (WIH), with an increase of 7.7 mL/kg body weight, based on a meta-analysis of multiple studies.
GIH also shows a potential improvement in endurance performance by approximately 2.62%, but more research is needed to confirm its effectiveness as an ergogenic aid, as the current data is limited.
A meta-analysis of the effects of glycerol-induced hyperhydration on fluid retention and endurance performance.Goulet, ED., Aubertin-Leheudre, M., Plante, GE., et al.[2019]
Glycerol has been proposed as a hyperhydrating agent that can improve fluid retention and potentially enhance athletic performance, especially in conditions where hydration is critical.
Research on glycerol's effectiveness has shown mixed results due to differences in study methods, but a common recommendation is to ingest 1 g/kg of glycerol with 1.5 L of fluid 60 to 120 minutes before competition, although some individuals may experience side effects like bloating or nausea.
Hyperhydrating with glycerol: implications for athletic performance.Wagner, DR.[2019]
Athletes can improve their hydration status and endurance performance by hyperhydrating with glycerol before exercise, as it helps retain fluid and enhances thermoregulation, allowing for greater tolerance to fluid loss.
To effectively hyperhydrate, athletes should consume glycerol at a dose of 1.2 g/kg body weight in 26 mL/kg body weight of fluid 30 minutes before exercise, with minimal side effects reported.
Guidelines for glycerol use in hyperhydration and rehydration associated with exercise.van Rosendal, SP., Osborne, MA., Fassett, RG., et al.[2021]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/41138915/
A randomized trial modeling the effects of solutions with ...At 210 min, fluid balance was predicted to be greater with ingestion of โ‰ฅ1.5% glycerol alone (-0.55ยฑ0.07% to -0.40ยฑ0.06%) or โ‰ฅ25 mM sodium alone ...
Effects of Beverage Volume, Glycerol Concentration, and ...The purpose of this study is to determine the effect of sodium and glycerol concentrations at various fluid intake volumes on fluid balance in healthy, ...
Glycerol-Enhanced Electrolyte Beverages for Fluid BalanceThe study tests if drinks with glycerol improve fluid balance better than a placebo drink that looks and tastes similar but doesn't have glycerol.
Effect of Glycerol-Electrolyte Beverages on Fluid Balance ...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.
Effect of Adding Glycerol to Electrolyte Beverages on Fluid ...The practical interpretation is that addition of glycerol enables a reduction in sodium concentration compared with a 0% glycerol drink.
Effect of Adding Glycerol to Electrolyte Beverages on Fluid ...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 ...
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