Hydration Solutions for Hydration
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two hydration solutions to determine their effectiveness compared to plain water. Researchers aim to discover whether adding amino acids to the Hydramin drink, a carbohydrate and electrolyte hydration solution, enhances hydration more than adding carbohydrates alone. Participants will consume different solutions on separate visits, with hydration measured through urine tests and blood glucose checks. Individuals who exercise moderately (about 5 hours a week or less) and do not have conditions affecting hydration balance may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding hydration solutions without the constraints of traditional clinical trial phases.
Do I need to stop taking my current medications for the trial?
Yes, you will need to stop taking any medications that may alter fluid retention or electrolyte levels, such as certain antidepressants, diabetes medications, laxatives, diuretics, and others. A nurse practitioner will review your medications to determine eligibility.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Past studies have checked drinks with carbohydrates and electrolytes for safety. When used as directed, these drinks are usually safe. Minor side effects, such as eye or skin irritation, are rare. Research on the Hydramin product shows that its ingredients are not dangerous when used properly. However, swallowing large amounts could be harmful, though normal use in hydration drinks should be safe. Overall, both treatments in these hydration drinks have a good safety record based on available evidence.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about these hydration solutions because they provide a more balanced and efficient way to rehydrate compared to standard water or electrolyte drinks. Unlike typical hydration options, these solutions combine carbohydrates and electrolytes in a specific formula that may enhance water absorption and retention in the body. This could be particularly beneficial for athletes, individuals in hot climates, or anyone needing rapid rehydration. By precisely targeting the body's hydration needs, these innovative solutions have the potential to improve performance and recovery times significantly.
What evidence suggests that this trial's treatments could be effective for hydration?
This trial will evaluate different hydration solutions, including a Carbohydrate and Electrolyte hydration solution, Hydramin, and Water. Studies have shown that drinks with carbohydrates and electrolytes help the body retain fluids more effectively than water alone, restoring hydration and balancing electrolytes. Research indicates that adding carbohydrates aids in the absorption of sodium and water, crucial for maintaining hydration. Hydramin, which contains amino acids, may further enhance hydration by balancing fluids and electrolytes. It may also speed recovery by reducing inflammation and boosting energy levels. Both options aim to hydrate more effectively than plain water. Participants in this trial will experience each hydration solution in different sequences to assess their effectiveness.16789
Are You a Good Fit for This Trial?
This trial is for adults (18+) with a BMI between 18.5 and 35 who are moderately active (up to 5 hours of aerobic exercise per week). Participants must be generally healthy, not have major medical conditions or take medications that affect hydration, and cannot be allergic to any ingredients in the drinks.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants consume different hydration solutions and are monitored for fluid balance and other physiological measures
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carbohydrate and Electrolyte hydration solution
- Hydramin
- Water
Trial Overview
The study compares how well three drinks hydrate: Hydramin (an electrolyte/amino acid solution), an electrolyte/carbohydrate solution, and plain water. Each participant will try all three drinks at different times. Researchers will measure urine output and blood sugar after each drink.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
At the beginning of each visit, subjects will arrive hydrated having consumed the standardized meal replacements the day before. Baseline measures will be taken and the subject will then consume one fourth of the randomly assigned condition provided to them every 7.5 minutes (1 liter total volume) over a 30-minute period. After the 1 liter is consumed, subjects will then be monitored for an additional four hours. Visit 1: Water Visit 2: Hydramin solution Visit 3: Electrolyte/Carbohydrate
At the beginning of each visit, subjects will arrive hydrated having consumed the standardized meal replacements the day before. Baseline measures will be taken and the subject will then consume one fourth of the randomly assigned condition provided to them every 7.5 minutes (1 liter total volume) over a 30-minute period. After the 1 liter is consumed, subjects will then be monitored for an additional four hours. Visit 1: Control Visit 2: Electrolyte/Carbohydrate Visit 3: Hydramin solution
At the beginning of each visit, subjects will arrive hydrated having consumed the standardized meal replacements the day before. Baseline measures will be taken and the subject will then consume one fourth of the randomly assigned condition provided to them every 7.5 minutes (1 liter total volume) over a 30-minute period. After the 1 liter is consumed, subjects will then be monitored for an additional four hours. Visit 1: Hydramin solution Visit 2: Water Visit 3: Electrolyte/Carbohydrate
At the beginning of each visit, subjects will arrive hydrated having consumed the standardized meal replacements the day before. Baseline measures will be taken and the subject will then consume one fourth of the randomly assigned condition provided to them every 7.5 minutes (1 liter total volume) over a 30-minute period. After the 1 liter is consumed, subjects will then be monitored for an additional four hours. Visit 1: Hydramin solution Visit 2: Electrolyte and Carbohydrate Visit 3: Water
At the beginning of each visit, subjects will arrive hydrated having consumed the standardized meal replacements the day before. Baseline measures will be taken and the subject will then consume one fourth of the randomly assigned condition provided to them every 7.5 minutes (1 liter total volume) over a 30-minute period. After the 1 liter is consumed, subjects will then be monitored for an additional four hours. Visit 1: Electrolyte/Carbohydrate Visit 2: Water Visit 3: Hydramin solution
At the beginning of each visit, subjects will arrive hydrated having consumed the standardized meal replacements the day before. Baseline measures will be taken and the subject will then consume one fourth of the randomly assigned condition provided to them every 7.5 minutes (1 liter total volume) over a 30-minute period. After the 1 liter is consumed, subjects will then be monitored for an additional four hours. Visit 1: Electrolyte/Carbohydrate Visit 2: Hydramin solution Visit 3: Water
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Memphis
Lead Sponsor
PharmaLinea Ltd.
Industry Sponsor
Citations
Oral Rehydration Beverages for Treating Exercise- ...
We conducted a systematic review to assess the effectiveness of carbohydrate-electrolyte (CE) solutions as a rehydration solution for exercise-associated ...
A Systematic Review, Part I. Carbohydrate-Electrolyte Solutions
Drinking 0% to 3.9% and especially 4% to 9% carbohydrate-electrolyte solution may restore volume/hydration status after exercising when whole foods are not ...
3.
frontiersin.org
frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2021.742710/fullHydration Is More Important Than Exogenous ...
Fluids with added components, especially salt or carbohydrates, can promote restoration of electrolytes and energy stores. These are often important ...
4.
news-medical.net
news-medical.net/news/20231113/Optimal-hydration-post-exercise-Study-compares-sodium-and-carbohydrate-levels-in-sports-drinks-for-effective-rehydration.aspxOptimal hydration post-exercise: Study compares sodium ...
In this study, researchers compared the effectiveness of sports drinks with varying carbohydrate and sodium levels for rehydrating athletes ...
Hydration: Are Electrolyte Drinks Better Than Water | Extension
A few studies have shown that electrolyte drinks do hydrate better than regular water 3,4 , but are they necessary? The answer: only in some circumstances.
Safety Data Sheet: Electrolyte solution
No special measures are necessary. 6.2. Environmental precautions. Keep away from drains, surface and ground water. 6.3. Methods and material for containment ...
Scientific Opinion on the substantiation of health claims ...
This opinion addresses the scientific substantiation of health claims in relation to carbohydrate-electrolyte solutions and reduction in rated perceived ...
SAFETY DATA SHEET
Use a NIOSH/MSHA approved respirator if there is a risk of exposure to dust/fume at levels exceeding the exposure limits. Ensure adequate ...
9.
foodstandards.gov.au
foodstandards.gov.au/sites/default/files/food-standards-code/proposals/Documents/Risk%20Assessment%20P1030%20Carbohydrate%20Composition.docx?csf=1&e=trLm2TRisk Assessment P1030 Carbohydrate Composition. ...
The European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies assessed health claims on carbohydrate-electrolyte solutions and a ...
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