Hydration
Conditions
Keywords
hydration, electrolytes, Hydramin, Beverage Hydration Index
Brief summary
In this study, the impact of two electrolyte hydration stick products (Hydramin containing an electrolyte/amino acid formulation and an identical electrolyte product with the amino-acids replaced with carbohydrate, dextrose) dissolved in 1 liter of water will be assessed and compared to a control (1 liter Smart Water). It is hypothesized that the addition of amino acids and glycine should improve the Beverage Hydration Index above water alone and perform comparably to the carbohydrate rich solution. This study will focus on general population (not athletes) and follow very similar approaches used in previous studies within the Center for Nutraceutical and Dietary Supplements Research, with the addition of blood glucose testing and body water measurements. Hydration will be assessed via fluid balance (the difference between the amount of water consumed and passed as urine) and calculations of beverage hydration index (the relative amount of urine passed after consumption of a drink compared to water)as well as time in positive fluid balance, and specific gravity, and sodium and potassium in urine. Blood glucose before and following consumption using finger pricks and a glucometer will also be assessed.
Interventions
DIETARY_SUPPLEMENTHydramin hydration solution
4 sticks of electrolyte and amino acid powder dissolved in 1 L Smart Water. Ingredients: Sodium, Chloride, Potassium, Magnesium, Vitamin C, AminoAbsorb (L-glutamine, L-Alanine, Glycine)
DIETARY_SUPPLEMENTCarbohydrate and Electrolyte hydration solution
4 sticks of electrolyte and carbohydrate powder dissolved in 1 L Smart Water. Ingredients: Sodium, Chloride, Potassium, Magnesium, Vitamin C, Dextrose
DIETARY_SUPPLEMENTWater
1 L Smart Water
Sponsors
University of Memphis
PharmaLinea Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Treatments will be assigned letters (A, B, C) and be provided to subjects in liquid form in opaque cups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be age 18 years or older * male or female * have a body mass index (BMI)between 18.5-35 kg/m2 (not morbidly obese) * Be engaged in moderate physical activity, defined as ≤5 hours/week of aerobic exercise * Not have a history or presence of a clinically relevant (that required or requires treatment) cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder (reviewed by Nurse practitioner) * Not have other conditions that are likely to alter fluid balance or be negatively affected by changing electrolyte levels/hydration status (as determined by Nurse practitioner) * Not be consuming any medication which may alter fluid retention/electrolyte levels such as Selective Serotonin Reuptake Inhibitors, sodium-glucose co-transporter 2 (SGLT2) inhibitor (for type 2 diabetes), laxatives, diuretics, Apremilast, chemotherapy, or lithium. (Medications will be reviewed by Nurse practitioner) * Not consume nutritional supplements, performance enhancing drugs, and/or non-steroidal anti-inflammatory drugs within 7 days of study visits excluding screening. * Follow the lifestyle and dietary restrictions before study visits (excluding screening/consenting visit) including before each visit avoiding strenuous activity for 24 hours prior, refrain from caffeine for 12 hours and alcohol for 24 hours, consume the standardized diet and maintain similar activity levels for 24 hours prior, consume 2.5 liters for men or 2.0 liters for women day prior, and fast (water only) of at least 10 hours prior. * Not have a sensitivity or be allergic to any components of the study interventions (water, calcium chloride, magnesium chloride, potassium bicarbonate, magnesium, sodium, chloride, potassium, vitamin C, dextrose, AminoAbsorb (L-alanine, L-glutamine, glycine). * Not be a tobacco user * Not be following a specialized dietary pattern that may alter findings (e.g., low carbohydrate/ketogenic diet, carnivore diet, intermittent fasting etc.) * Arrive to lab for visits euhydrated (USG 1.005-1.020) * Have the ability and willingness to fast (consume water/treatments only) for 15 hours (10 hours prior to lab visits not including screening) * Not be enrolled in another clinical study within 30 days of the first study visit * Be without active infection or illness of any kind * Not be pregnant or breastfeeding * Not have surgery in the previous 4 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beverage Hydration Index | 0 minutes after beverage consumption | Beverage Hydration Index calculated as mass of urine collected following control (water) divided by the mass of urine collected following treatment |
| Net Fluid Balance | 0 minutes after beverage consumption | Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed |
| Urine Specific Gravity | 0 minutes before beverage consumption | Urine Specific Gravity measured via refractometry. |
| Urine Sodium | 0 minutes before beverage consumption | Urine sodium will be measured in millimoles per kilogram of water |
| Urine Potassium | 0 minutes before beverage consumption | Urine Potassium will be measured in millimoles per kilogram of water |
| Body mass | 0 minutes before beverage consumption | Body Mass in kilograms will be measured using a digital scale |
| Body Water | 0 minutes before beverage consumption | Body water will be determined using a digital bioelectrical impedance analysis scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mood and Digestive Questionnaire | 0 minutes before beverage consumption | Subjects will be asked to self-assess their mood and digestive state via a visual analog scale questionnaire with scale 0 (None) to 10 (Extreme) where higher scores for positive mood attributes indicating a better outcome and higher scores for both negative mood attributes and digestive traits generally indicating a worse outcome. |
| Diastolic Blood Pressure | 0 minutes before beverage consumption | Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff |
| Systolic Blood Pressure | 0 minutes before beverage consumption | Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff |
| Heart Rate | 0 minutes before beverage consumption | Heart rate will be measured in beats per minute using an automated cuff |
| Blood Glucose | 0 minutes before beverage consumption | Blood glucose will be measured in milligrams per deciliter using a glucometer |
Countries
United States
Outcome results
None listed