Beverage Hydration Index of Different Solutions
Purpose
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.
Condition
- Hydration
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
- Masking Description
- Treatments will be assigned letters (A, B, C) and be provided to subjects in liquid form in opaque cups.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Hydramin, Electrolyte and Carbohydrate, 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: Hydramin solution Visit 2: Electrolyte and Carbohydrate Visit 3: Water |
|
|
Experimental Hydramin, Water, Electrolyte and 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: Water Visit 3: Electrolyte/Carbohydrate |
|
|
Experimental Electrolyte and Carbohydrate, Hydramin, 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: Hydramin solution Visit 3: Water |
|
|
Experimental Electrolyte and Carbohydrate, Water, Hydramin |
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 |
|
|
Experimental Water, Hydramin, Electrolyte and 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: Water Visit 2: Hydramin solution Visit 3: Electrolyte/Carbohydrate |
|
|
Experimental Water, Electrolyte and Carbohydrate, Hydramin |
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 |
|
Recruiting Locations
Memphis, Tennessee 38152
Jackie Pence, PhD
More Details
- Status
- Recruiting
- Sponsor
- University of Memphis