Electrolyte Drinks for Dehydration

(LIV-D2O Trial)

Overseen By Stavros Kavouras, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: Thyroid medication

Disqualifiers: Cardiovascular, Renal, Hepatic, others

Compensation: Varies

Number of Visits: 2

Duration: 4 hours

20 Participants Needed

Trial Summary

What is the purpose of this trial?

It is well established that rehydration with a carbohydrate-electrolyte solution is more effective in comparison to plain water. This is primarily based on the sodium-glucose co transporter, based on which the world health organization has based its oral rehydration solution recommendations. Also, rehydration with a solution that includes sodium and glucose plasma osmolality should not drop as much as it happens during rehydration with water. As a result, we should have higher fluid intake due to higher thirst perception and lower urinary output due to higher levels of vasopressin. The present study aims to examine the effectiveness of a electrolyte-glucose drink on rehydration following exercise-induced dehydration.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on thyroid medication.

Is it safe to use electrolyte drinks for dehydration?

Research shows that oral rehydration solutions (ORS), including those with glucose and electrolytes, are generally safe for treating dehydration in humans, including children with gastroenteritis. No adverse effects were reported in studies, but it's important to use the correct formulation for specific conditions, like cholera, to avoid complications such as low sodium levels. ^{1 2 3 4 5}

How is the treatment Liquid IV Hydration Multiplier different from other treatments for dehydration?

Liquid IV Hydration Multiplier is unique because it offers a convenient oral rehydration solution (ORS) that can be used at home, combining electrolytes and glucose to effectively rehydrate the body. Unlike some traditional ORS formulations, it may provide a more balanced electrolyte composition suitable for both cholera and non-cholera dehydration, potentially reducing the risk of complications like hyponatremia (low sodium levels). ^{1 2 4 6 7}

Eligibility Criteria

This trial is for adults aged 18-60 who exercise at least twice a week and have maintained a stable weight (less than 5 pounds change) over the last two months. It's not suitable for those with night shift work, on thyroid meds, past bariatric surgery, or with heart, kidney, liver diseases. Also excluded are those in another study or weighing over 110 pounds.

Inclusion Criteria

Training at least 2 times per week

Stable weight for the last 2 months (fluctuation less than 5 pounds)

I am between 18 and 60 years old.

Exclusion Criteria

I have a heart condition.

Night shifting work

I have had weight loss surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo rehydration with either a carbohydrate-electrolyte solution or water following exercise-induced dehydration

4 hours

1 visit (in-person)

Follow-up

Participants are monitored for rehydration effectiveness and physiological responses

4 hours

1 visit (in-person)

Treatment Details

Interventions

• Liquid IV Hydration Multiplier
• Liquid IV Sugar Free

Trial Overview The study tests how well different drinks rehydrate after exercise-induced dehydration: plain water versus Liquid IV Sugar Free and Liquid IV Hydration Multiplier—both containing electrolytes and glucose which may enhance fluid intake and reduce urine output.

Participant Groups

Group I: Low Sugar electrolyte solution Experimental Treatment 1 Intervention

10 grams of carbohydrate, 1060 milligrams of sodium, and 760 milligrams of potassium per liter. Sugar free Liquid IV

Group II: Carbohydrate Electrolyte solution Experimental Treatment 1 Intervention

Drink with 22 grams of carbohydrate, 1020 milligrams of sodium, and 760 milligrams of potassium per liter. Hydration multiplier liquid IV

Group III: Water Placebo Group 1 Intervention

Rehydration with low mineral content bottle water

Liquid IV Hydration Multiplier is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as Oral Rehydration Solution (ORS) for:

• Dehydration due to diarrhea
• Dehydration due to vomiting
• Exercise-induced dehydration

Approved in United States as Oral Rehydration Therapy (ORT) for:

• Mild to moderate dehydration
• Diarrhea
• Vomiting
• Exercise-induced dehydration

Approved in United Kingdom as Oral Rehydration Solution (ORS) for:

• Dehydration due to diarrhea
• Dehydration due to vomiting

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Findings from Research

Oral rehydration therapy (ORT) using glucose-electrolyte solutions is a highly effective treatment for acute diarrheal diseases, recognized as one of the major therapeutic advancements of the century.

The World Health Organization's recommended oral rehydration solution (ORS) is widely used and has potential applications beyond diarrhea, including in patients with short bowel syndrome and post-surgical recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral rehydration therapy. Farthing, MJ.[2019]

In a study involving 26 healthy adults, an amino acid-based oral rehydration therapy (ORT) beverage showed significantly better fluid retention (75% vs 57%) and improved restoration of interstitial fluid volume compared to a glucose-based sports drink after hypertonic dehydration.

During isotonic dehydration, the amino acid beverage also outperformed the sports drink in electrolyte replacement and preservation of interstitial fluid volume, indicating its potential as a more effective rehydration option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Glucose or Amino Acid-Based Commercial Beverages in Meeting Oral Rehydration Therapy Goals After Acute Hypertonic and Isotonic Dehydration. Cheuvront, SN., Kenefick, RW., Charkoudian, N., et al.[2019]

A new oral rehydration solution (ORS) called reformulated Dioralyte (RD) was tested in a double-blind trial with 32 children suffering from acute gastroenteritis, showing no adverse effects from either RD or the standard Dioralyte (SD).

Both RD and SD had similar efficacy in terms of fluid intake, weight change, and stool frequency, indicating that RD, with its lower osmolality, is as effective as the standard solution for rehydration in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience with a hypotonic oral rehydration solution for treatment of pediatric gastroenteritis in the United Kingdom. Elliott, EJ., Walker-Smith, JA., Farthing, MJ., et al.[2016]

Using low-sodium oral rehydration solutions (ORS) for treating cholera can lead to negative sodium balance and potentially dangerous complications like hyponatremia and seizures, especially in children.

The review recommends maintaining separate ORS formulations for cholera and non-cholera acute watery diarrheas to ensure safe and effective treatment, highlighting the importance of sodium levels in rehydration therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Issues and Controversies in the Evolution of Oral Rehydration Therapy (ORT). Nalin, D.[2022]

In a study with 20 healthy participants, the amino acid-based sugar-free oral rehydration solution (AA-ORS) was found to be more effective than both glucose-based (G-ORS) and sugar-free (Z-ORS) solutions in restoring fluid balance after exercise-induced dehydration.

AA-ORS not only improved overall fluid balance but also achieved a positive sodium and chloride balance post-exercise, indicating it may be a superior option for rehydration compared to the other solutions tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-exercise rehydration: Comparing the efficacy of three commercial oral rehydration solutions. Peden, DL., Funnell, MP., Reynolds, KM., et al.[2023]

Oral rehydration therapy (ORT) effectively prevents and treats dehydration by providing a balanced mix of electrolytes, significantly reducing mortality rates in patients with cholera and non-cholera watery diarrhea.

ORT can be safely administered at home, highlighting the importance of health authorities in ensuring the availability of oral rehydration salts (ORS) and training health workers to prepare these solutions for emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of oral rehydration therapy in controlling epidemic of cholera and watery diarrhoea. Sarkar, K.[2004]

For children with mild-to-moderate dehydration due to diarrhea, oral rehydration therapy (ORT) using solutions with 45-75 mEq/l of sodium is recommended, while those with severe dehydration should receive intravenous fluids (60-100 ml/kg of 0.9% saline) to quickly restore circulation.

The study emphasizes the importance of tailoring rehydration solutions based on the type of dehydration, with specific recommendations for isonatremic, hyponatremic, and hypernatremic dehydration to ensure safe and effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simplified treatment strategies to fluid therapy in diarrhea. Assadi, F., Copelovitch, L.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Oral rehydration therapy. [2019]

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

Efficacy of Glucose or Amino Acid-Based Commercial Beverages in Meeting Oral Rehydration Therapy Goals After Acute Hypertonic and Isotonic Dehydration. [2019]

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

Clinical experience with a hypotonic oral rehydration solution for treatment of pediatric gastroenteritis in the United Kingdom. [2016]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Issues and Controversies in the Evolution of Oral Rehydration Therapy (ORT). [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Post-exercise rehydration: Comparing the efficacy of three commercial oral rehydration solutions. [2023]

6. India pubmed.ncbi.nlm.nih.gov

Role of oral rehydration therapy in controlling epidemic of cholera and watery diarrhoea. [2004]

7. Germany pubmed.ncbi.nlm.nih.gov

Simplified treatment strategies to fluid therapy in diarrhea. [2018]