Beverage Composition 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

Disqualifiers: Cardiovascular, Renal, Metabolic diseases, others

Compensation: Varies

Number of Visits: 7

Duration: 1 week

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The presence of certain ingredients such as sodium and glycerol can facilitate retention of the fluid consumed via renal water reabsorption. To maintain overall whole-body fluid balance, it is important that ingested fluid is retained in the body instead of losing it through urination. 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, euhydrated men and women.

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 increase urination). If you are on any medication, it's best to discuss it with the study investigator to see if it might affect your participation.

Is the beverage composition for fluid balance safe for humans?

Research on glycerol, a component of the beverage, shows it is generally safe for humans, though some people may experience mild side effects like nausea or stomach discomfort. Studies have not shown any major health risks associated with its use in hydration solutions. ^{1 2 3 4 5}

How does the treatment with electrolyte solution and glycerol differ from other treatments for fluid balance?

This treatment is unique because it includes glycerol, which has been shown to enhance water absorption and sodium transport in the intestines, potentially making it more effective at maintaining fluid balance compared to other electrolyte solutions without glycerol. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Electrolyte solution with glycerol for fluid balance?

Research shows that adding glycerol to an electrolyte solution can improve fluid retention and reduce urine production more effectively than using salt or glycerol alone. This suggests that glycerol can help maintain better fluid balance in the body. ^{3 9 10 11 12}

Who Is on the Research Team?

Lawrence Galitz, MD

Principal Investigator

GCP Research

Are You a Good Fit for This Trial?

Healthy, active men and women aged 18-50 who don't smoke or take interfering medications can join this trial. They must not be pregnant, avoid alcohol before visits, fast overnight, refrain from vigorous exercise for a day prior, and eat the same food before each lab visit.

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 refrain from vigorous exercise for 24 hours

Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)

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 6 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 consume various beverages with different concentrations of sodium and glycerol to assess fluid balance

1 week

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Electrolyte solution with glycerol
• Electrolyte solution without glycerol
• Placebo beverage

Trial Overview The study is testing how different electrolyte solutions with varying volumes and concentrations of glycerol affect fluid retention in the body. Participants will try several beverages to see which helps maintain fluid balance best without being lost through urination.

How Is the Trial Designed?

Group I: Electrolyte solution without glycerol beverage 3 Experimental Treatment 1 Intervention

Higher electrolytes higher volume

Group II: Electrolyte solution without glycerol beverage 2 Experimental Treatment 1 Intervention

Lower electrolytes mid-volume

Group III: Electrolyte solution without glycerol beverage 1 Experimental Treatment 1 Intervention

Higher electrolytes lower volume

Group IV: Electrolyte solution with glycerol beverage 3 Experimental Treatment 1 Intervention

Higher electrolytes, higher glycerol, higher volume

Group V: Electrolyte solution with glycerol beverage 2 Experimental Treatment 1 Intervention

Higher electrolytes, higher glycerol, lower volume

Group VI: Electrolyte solution with glycerol beverage 1 Experimental Treatment 1 Intervention

Lower electrolytes, lower glycerol, lower volume

Group VII: Base with glycerol beverage 3 Experimental Treatment 1 Intervention

No electrolytes, higher glycerol, higher volume

Group VIII: Base with glycerol beverage 2 Experimental Treatment 1 Intervention

No electrolytes, lower glycerol, mid-volume

Group IX: Base with glycerol beverage 1 Experimental Treatment 1 Intervention

No electrolytes, higher glycerol, lower volume

Group X: 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

Published Research Related to This Trial

In a study using a rat intestine perfusion model, a high-energy beverage combining glycerol (Gly) and corn syrup (CS) was found to significantly improve water absorption compared to commercial products containing sucrose and glucose-fructose syrups.

Gly not only enhanced water absorption but also reduced sodium release into the intestinal lumen, suggesting it could be an effective ingredient in energy-rich beverages to improve fluid absorption in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancement of intestinal water absorption and sodium transport by glycerol in rats. Wapnir, RA., Sia, MC., Fisher, SE.[2017]

In a trial involving six patients on continuous ambulatory peritoneal dialysis, switching from glucose to glycerol as the osmotic agent did not significantly reduce the energy load, with similar daily energy values of 1607 kJ for glycerol and 1669 kJ for glucose.

While glycerol treatment maintained fluid balance, it led to increased fasting plasma triglyceride levels by 50% and caused hyperosmolality symptoms in one patient, indicating potential safety concerns with glycerol use in dialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of glycerol as an osmotic agent for continuous ambulatory peritoneal dialysis in end-stage renal failure. Heaton, A., Ward, MK., Johnston, DG., et al.[2019]

Combining sodium and glycerol in a hyperhydration solution (SGIH) significantly reduces urine production and enhances fluid retention compared to using sodium (SIH) or glycerol (GIH) alone, as shown in a study with 15 young men over a 3-hour period.

The study found that while plasma volume changes were similar across all hyperhydration methods, SGIH resulted in the highest fluid retention (1,435 ml) and the lowest urine output (551 ml), indicating its potential for optimizing hydration strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salt + Glycerol-Induced Hyperhydration Enhances Fluid Retention More Than Salt- or Glycerol-Induced Hyperhydration. Goulet, EDB., De La Flore, A., Savoie, FA., et al.[2018]

The review highlights that using an oral glucose electrolyte solution can effectively reduce mortality from acute diarrhea in children to nearly zero, while minimizing negative impacts on electrolyte balance and nutrition.

The recommended therapy simplifies treatment by advocating for a single oral glucose electrolyte solution for all age groups and encourages early feeding with tolerated foods, which contrasts with traditional methods that may not be as effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of acute diarrhea in children. An historical and physiological perspective. Hirschhorn, N.[2022]

In a study involving children under 18 months with acute gastroenteritis, it was found that parents often prepared carbohydrate electrolyte solutions inaccurately, leading to potentially high osmolality in glucose-based solutions.

The research suggests that sucrose-based electrolyte sachets may be a better option for outpatient treatment in developed countries, as they showed more consistent osmolality and could be made widely available for home use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral solutions for infantile gastroenteritis--variations in composition. Hutchins, P., Wilson, C., Manly, JA., et al.[2019]

In a study with nine subjects cycling for 90 minutes in a warm environment, consuming glycerol solutions led to increased plasma osmolality and helped maintain plasma volume compared to water, but did not show significant benefits for cardiovascular or thermoregulatory responses.

Despite some changes in hormone levels and perceived thirst, the glycerol solutions did not provide substantial advantages over standard carbohydrate-electrolyte beverages or water in terms of exercise performance or metabolic responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological responses to glycerol ingestion during exercise. Murray, R., Eddy, DE., Paul, GL., et al.[2017]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for glycerol use in hyperhydration and rehydration associated with exercise. van Rosendal, SP., Osborne, MA., Fassett, RG., et al.[2021]

Ingesting glycerol with water before exercise helps retain fluid, leading to lower heart rates and better thermoregulation during intense cycling in hot conditions, as shown in a study with six endurance-trained men.

This glycerol ingestion improved exercise performance by 5% compared to a control, indicating that it enhances endurance in the heat without significantly changing muscle metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of glycerol-induced hyperhydration on thermoregulation and metabolism during exercise in heat. Anderson, MJ., Cotter, JD., Garnham, AP., et al.[2019]

The study evaluated two carbohydrate-electrolyte solutions designed to meet the hydration and electrolyte needs of troops training in hot weather, highlighting their multipurpose use in various scenarios.

These solutions can effectively replace fluids and electrolytes during intense physical activity, aid in recovery from mild heat-related illnesses, and serve as oral rehydration therapy for diarrhea, making them essential for maintaining troop performance and safety in extreme conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbohydrate-electrolyte solutions during field training: an overview. Szlyk, PC., Rose, MS., Francesconi, RP., et al.[2017]

Gatorade was the only beverage among those tested that effectively restored hydration status after exercise-induced dehydration, while Apfelschorle, Evian, and San Benedetto mineral water left participants in a lower hydration state.

Despite common perceptions, many traditional rehydration drinks do not provide sufficient sodium to restore fluid balance after dehydration, highlighting the need for beverages with appropriate electrolyte compositions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehydration after exercise in the heat: a comparison of 4 commonly used drinks. Shirreffs, SM., Aragon-Vargas, LF., Keil, M., et al.[2019]

A study of 91 commercial dietary clear fluids revealed significant variability in sodium, potassium, and sugar content, making them unsuitable for treating diarrhea.

Only 'Unicef Oral Rehydration Salts' has been clinically proven to be safe and effective for diarrhea treatment, while the formulation of Diolyte is also deemed appropriate for mild dehydration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral rehydration fluids used in the treatment of diarrhoea. Analysis of the osmolalities, and sodium, potassium and sugar contents of commercial and home-made products. Dibley, M., Phillips, F., Mahoney, TJ., et al.[2013]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Enhancement of intestinal water absorption and sodium transport by glycerol in rats. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of glycerol as an osmotic agent for continuous ambulatory peritoneal dialysis in end-stage renal failure. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Salt + Glycerol-Induced Hyperhydration Enhances Fluid Retention More Than Salt- or Glycerol-Induced Hyperhydration. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

The treatment of acute diarrhea in children. An historical and physiological perspective. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Oral solutions for infantile gastroenteritis--variations in composition. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Physiological responses to glycerol ingestion during exercise. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Hyperhydrating with glycerol: implications for athletic performance. [2019]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Guidelines for glycerol use in hyperhydration and rehydration associated with exercise. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of glycerol-induced hyperhydration on thermoregulation and metabolism during exercise in heat. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Carbohydrate-electrolyte solutions during field training: an overview. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Rehydration after exercise in the heat: a comparison of 4 commonly used drinks. [2019]

12. Australia pubmed.ncbi.nlm.nih.gov

Oral rehydration fluids used in the treatment of diarrhoea. Analysis of the osmolalities, and sodium, potassium and sugar contents of commercial and home-made products. [2013]