Glycerol-Electrolyte Beverage for Fluid Balance

Overseen By Lindsay Baker, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: PepsiCo Global R&D

Must not be taking: Diuretics, Laxatives, Weight loss drugs

Disqualifiers: Cardiovascular, Renal, Metabolic diseases, others

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special drink with glycerol and electrolytes affects fluid balance in healthy men and women. The study compares this experimental beverage to a placebo (a drink without active ingredients) to determine which better helps the body retain fluids. It suits generally healthy, active individuals who exercise regularly and do not have conditions like heart or kidney diseases. Participants should also be willing to follow guidelines such as avoiding alcohol and eating the same meals before study visits. As an unphased trial, this study allows participants to contribute to the scientific understanding of hydration in active individuals.

Will I have to stop taking my current medications?

You may need to stop taking certain medications that could interfere with the study, like diuretics, laxatives, or weight loss drugs. It's best to discuss your current medications with the study team to see if any changes are needed.

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

Research has shown that glycerol and sodium, the main ingredients in the experimental drink, help the body stay hydrated by prompting the kidneys to retain more water. In past studies, participants who consumed drinks containing glycerol maintained better fluid balance, even during exercise.

These studies primarily assess the drink's effectiveness and do not report any serious side effects, suggesting that the glycerol-electrolyte drink is generally safe. Since the trial is not in a specific phase, it likely focuses more on the drink's impact on fluid balance than on safety concerns. Prospective participants might find this information reassuring regarding the drink's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Glycerol-Electrolyte Beverage is unique because it combines glycerol with electrolytes, which sets it apart from standard hydration solutions that typically only contain electrolytes. This combination could enhance fluid retention and improve hydration more effectively by drawing more water into the body's cells. Researchers are excited about this treatment because it may offer a superior solution for maintaining fluid balance, especially in situations where dehydration is a risk, such as during intense exercise or in hot climates.

What evidence suggests that the Glycerol-Electrolyte Beverage is effective for fluid balance?

Research has shown that glycerol and sodium help the body retain more fluids by prompting the kidneys to conserve water, reducing urine output. Studies have found that drinks containing glycerol and electrolytes result in less urination compared to those without them. This trial will compare an experimental glycerol-electrolyte beverage with a placebo beverage to evaluate their effects on hydration. These findings are particularly beneficial for healthy, active individuals seeking to maintain good hydration. ^{1 2 4 6 7}

Who Is on the Research Team?

Lindsay Baker

Principal Investigator

PepsiCo R&D/Gatorade and Sports Science Institute

Are You a Good Fit for This Trial?

This trial is for healthy men and women who are properly hydrated (euhydrated). Specific eligibility criteria details were not provided, so it's assumed that participants should be generally healthy without any major health issues.

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)

Subject is willing to eat the exact same food the day prior to each study session

I am not on medications like diuretics, laxatives, or weight loss drugs.

Exclusion Criteria

Subject has participated in a clinical trial within the past 30 days

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 has participated in any PepsiCo trial within past 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either a glycerol-electrolyte beverage or a placebo beverage to assess fluid balance

3 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Glycerol-Electrolyte Beverage

Trial Overview The study is testing the effects of a glycerol-electrolyte beverage on maintaining fluid balance compared to a placebo drink. Both beverages are kiwi-strawberry flavored. The goal is to see if the experimental drink helps retain more fluids in the body.

How Is the Trial Designed?

Group I: Experimental Beverage Experimental Treatment 1 Intervention

Glycerol beverage with electrolytes

Group II: Placebo Beverage Placebo Group 1 Intervention

Base beverage, no electrolytes, no glycerol

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

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S000291652500615X

A randomized trial modeling the effects of solutions with ... At 210 min, fluid balance was predicted to be greater with ingestion of ≥1.5% glycerol alone (-0.55±0.07% to -0.40±0.06%) or ≥25 mM sodium alone ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06185595

Effect of Glycerol-Electrolyte Beverages on Fluid Balance ... Study Overview. The objective of this study is to determine the effect of consumption of drinks with varying amounts of glycerol and electrolytes on fluid ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41138915/

A randomized trial modeling the effects of solutions with ... These results help inform the minimum concentrations of glycerol and/or sodium needed to promote fluid balance in healthy, active individuals; ...

4. trialx.com trialx.com/clinical-trials/listings/325162/effects-of-a-glycerol-electrolyte-beverage-on-fluid-balance-in-healthy-euhydrated-men-and-women/

Effects of a Glycerol-Electrolyte Beverage on Fluid Balance ... Overview. Glycerol and sodium are osmotically-active ingredients that promote fluid retention via renal water reabsorption.

5. cdnsciencepub.com cdnsciencepub.com/doi/abs/10.1139/apnm-2023-0483

Effects of ingesting beverages containing glycerol and ... Total urine volume was reduced in all beverages containing glycerol and sodium compared to CON (all P ≤ 0.002). The addition of isomaltulose increased BHI by ∼ ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/2402207/

Effects of glycerol-induced hyperhydration prior to exercise in ... These data support the hypothesis that glycerol-induced hyperhydration reduces the thermal burden of moderate exercise in the heat.

7. ctv.veeva.com ctv.veeva.com/study/effect-of-glycerol-electrolyte-beverages-on-fluid-balance-in-healthy-euhydrated-men-and-women-at-res

Effect of Glycerol-Electrolyte Beverages on Fluid Balance in ... The objective of this study is to determine the effect of consumption of drinks with varying amounts of glycerol and electrolytes on fluid ...