- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07507344
Beverage Hydration Index of Different Solutions
Comparison of the Beverage Hydration Index of Different Solutions
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jacquelyn Pence, PhD
- Phone Number: 901-678-1547
- Email: jpence1@memphis.edu
Study Contact Backup
- Name: Richard Bloomer, PhD
- Email: rbloomer@memphis.edu
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38152
- Recruiting
- Center for Nutraceutical and Dietary Supplement Research
-
Contact:
- Jackie Pence, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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 |
4 sticks of electrolyte and carbohydrate powder dissolved in 1 L Smart Water.
Ingredients: Sodium, Chloride, Potassium, Magnesium, Vitamin C, Dextrose
1 L Smart Water
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)
|
|
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 |
4 sticks of electrolyte and carbohydrate powder dissolved in 1 L Smart Water.
Ingredients: Sodium, Chloride, Potassium, Magnesium, Vitamin C, Dextrose
1 L Smart Water
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)
|
|
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 |
4 sticks of electrolyte and carbohydrate powder dissolved in 1 L Smart Water.
Ingredients: Sodium, Chloride, Potassium, Magnesium, Vitamin C, Dextrose
1 L Smart Water
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)
|
|
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 |
4 sticks of electrolyte and carbohydrate powder dissolved in 1 L Smart Water.
Ingredients: Sodium, Chloride, Potassium, Magnesium, Vitamin C, Dextrose
1 L Smart Water
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)
|
|
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 |
4 sticks of electrolyte and carbohydrate powder dissolved in 1 L Smart Water.
Ingredients: Sodium, Chloride, Potassium, Magnesium, Vitamin C, Dextrose
1 L Smart Water
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)
|
|
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 |
4 sticks of electrolyte and carbohydrate powder dissolved in 1 L Smart Water.
Ingredients: Sodium, Chloride, Potassium, Magnesium, Vitamin C, Dextrose
1 L Smart Water
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Net Fluid Balance
Time Frame: 0 minutes after beverage consumption
|
Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed
|
0 minutes after beverage consumption
|
|
Net Fluid Balance
Time Frame: 60 minutes after beverage consumption
|
Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed
|
60 minutes after beverage consumption
|
|
Net Fluid Balance
Time Frame: 120 minutes after beverage consumption
|
Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed
|
120 minutes after beverage consumption
|
|
Net Fluid Balance
Time Frame: 180 minutes after beverage consumption
|
Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed
|
180 minutes after beverage consumption
|
|
Net Fluid Balance
Time Frame: 240 minutes after beverage consumption
|
Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed
|
240 minutes after beverage consumption
|
|
Beverage Hydration Index
Time Frame: 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
|
0 minutes after beverage consumption
|
|
Beverage Hydration Index
Time Frame: 60 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
|
60 minutes after beverage consumption
|
|
Beverage Hydration Index
Time Frame: 120 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
|
120 minutes after beverage consumption
|
|
Beverage Hydration Index
Time Frame: 180 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
|
180 minutes after beverage consumption
|
|
Beverage Hydration Index
Time Frame: 240 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
|
240 minutes after beverage consumption
|
|
Urine Specific Gravity
Time Frame: 0 minutes before beverage consumption
|
Urine Specific Gravity measured via refractometry.
|
0 minutes before beverage consumption
|
|
Urine Specific Gravity
Time Frame: 0 minutes after beverage consumption
|
Urine Specific Gravity measured via refractometry.
|
0 minutes after beverage consumption
|
|
Urine Specific Gravity
Time Frame: 60 minutes after beverage consumption
|
Urine Specific Gravity measured via refractometry.
|
60 minutes after beverage consumption
|
|
Urine Specific Gravity
Time Frame: 120 minutes after beverage consumption
|
Urine Specific Gravity measured via refractometry.
|
120 minutes after beverage consumption
|
|
Urine Specific Gravity
Time Frame: 180 minutes after beverage consumption
|
Urine Specific Gravity measured via refractometry.
|
180 minutes after beverage consumption
|
|
Urine Specific Gravity
Time Frame: 240 minutes after beverage consumption
|
Urine Specific Gravity measured via refractometry.
|
240 minutes after beverage consumption
|
|
Urine Sodium
Time Frame: 0 minutes before beverage consumption
|
Urine sodium will be measured in millimoles per kilogram of water
|
0 minutes before beverage consumption
|
|
Urine Sodium
Time Frame: 0 minutes after beverage consumption
|
Urine sodium will be measured in milliosmoles per kilogram of water
|
0 minutes after beverage consumption
|
|
Urine Sodium
Time Frame: 60 minutes after beverage consumption
|
Urine sodium will be measured in millimoles per kilogram of water
|
60 minutes after beverage consumption
|
|
Urine Sodium
Time Frame: 120 minutes after beverage consumption
|
Urine sodium will be measured in milliosmoles per kilogram of water
|
120 minutes after beverage consumption
|
|
Urine Sodium
Time Frame: 180 minutes after beverage consumption
|
Urine sodium will be measured in millimoles per kilogram of water
|
180 minutes after beverage consumption
|
|
Urine Sodium
Time Frame: 240 minutes after beverage consumption
|
Urine sodium will be measured in millimoles per kilogram of water
|
240 minutes after beverage consumption
|
|
Urine Potassium
Time Frame: 0 minutes before beverage consumption
|
Urine Potassium will be measured in millimoles per kilogram of water
|
0 minutes before beverage consumption
|
|
Urine Potassium
Time Frame: 0 minutes after beverage consumption
|
Urine Potassium will be measured in millimoles per kilogram of water
|
0 minutes after beverage consumption
|
|
Urine Potassium
Time Frame: 60 minutes after beverage consumption
|
Urine Potassium will be measured in millimoles per kilogram of water
|
60 minutes after beverage consumption
|
|
Urine Potassium
Time Frame: 120 minutes after beverage consumption
|
Urine Potassium will be measured in millimoles per kilogram of water
|
120 minutes after beverage consumption
|
|
Urine Potassium
Time Frame: 180 minutes after beverage consumption
|
Urine Potassium will be measured in millimoles per kilogram of water
|
180 minutes after beverage consumption
|
|
Urine Potassium
Time Frame: 240 minutes after beverage consumption
|
Urine Potassium will be measured in millimoles per kilogram of water
|
240 minutes after beverage consumption
|
|
Body mass
Time Frame: 0 minutes before beverage consumption
|
Body Mass in kilograms will be measured using a digital scale
|
0 minutes before beverage consumption
|
|
Body mass
Time Frame: 240 minutes after beverage consumption
|
Body Mass in kilograms will be measured using a digital scale
|
240 minutes after beverage consumption
|
|
Body Water
Time Frame: 0 minutes before beverage consumption
|
Body water will be determined using a digital bioelectrical impedance analysis scale.
|
0 minutes before beverage consumption
|
|
Body Water
Time Frame: 120 minutes after beverage consumption
|
Body water will be determined using a digital bioelectrical impedance analysis scale.
|
120 minutes after beverage consumption
|
|
Body Water
Time Frame: 240 minutes after beverage consumption
|
Body water will be determined using a digital bioelectrical impedance analysis scale.
|
240 minutes after beverage consumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diastolic Blood Pressure
Time Frame: 0 minutes before beverage consumption
|
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff
|
0 minutes before beverage consumption
|
|
Diastolic Blood Pressure
Time Frame: 0 minutes after beverage consumption
|
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff
|
0 minutes after beverage consumption
|
|
Diastolic Blood Pressure
Time Frame: 60 minutes after beverage consumption
|
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff
|
60 minutes after beverage consumption
|
|
Diastolic Blood Pressure
Time Frame: 120 minutes after beverage consumption
|
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff
|
120 minutes after beverage consumption
|
|
Diastolic Blood Pressure
Time Frame: 180 minutes after beverage consumption
|
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff
|
180 minutes after beverage consumption
|
|
Diastolic Blood Pressure
Time Frame: 240 minutes after beverage consumption
|
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff
|
240 minutes after beverage consumption
|
|
Systolic Blood Pressure
Time Frame: 0 minutes before beverage consumption
|
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff
|
0 minutes before beverage consumption
|
|
Systolic Blood Pressure
Time Frame: 0 minutes after beverage consumption
|
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff
|
0 minutes after beverage consumption
|
|
Systolic Blood Pressure
Time Frame: 60 minutes after beverage consumption
|
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff
|
60 minutes after beverage consumption
|
|
Systolic Blood Pressure
Time Frame: 120 minutes after beverage consumption
|
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff
|
120 minutes after beverage consumption
|
|
Systolic Blood Pressure
Time Frame: 180 minutes after beverage consumption
|
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff
|
180 minutes after beverage consumption
|
|
Systolic Blood Pressure
Time Frame: 240 minutes after beverage consumption
|
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff
|
240 minutes after beverage consumption
|
|
Heart Rate
Time Frame: 0 minutes before beverage consumption
|
Heart rate will be measured in beats per minute using an automated cuff
|
0 minutes before beverage consumption
|
|
Heart Rate
Time Frame: 0 minutes after beverage consumption
|
Heart rate will be measured in beats per minute using an automated cuff
|
0 minutes after beverage consumption
|
|
Heart Rate
Time Frame: 60 minutes after beverage consumption
|
Heart rate will be measured in beats per minute using an automated cuff
|
60 minutes after beverage consumption
|
|
Heart Rate
Time Frame: 120 minutes after beverage consumption
|
Heart rate will be measured in beats per minute using an automated cuff
|
120 minutes after beverage consumption
|
|
Heart Rate
Time Frame: 180 minutes after beverage consumption
|
Heart rate will be measured in beats per minute using an automated cuff
|
180 minutes after beverage consumption
|
|
Heart Rate
Time Frame: 240 minutes after beverage consumption
|
Heart rate will be measured in beats per minute using an automated cuff
|
240 minutes after beverage consumption
|
|
Blood Glucose
Time Frame: 0 minutes before beverage consumption
|
Blood glucose will be measured in milligrams per deciliter using a glucometer
|
0 minutes before beverage consumption
|
|
Blood Glucose
Time Frame: 40 minutes after beverage consumption
|
Blood glucose will be measured in milligrams per deciliter using a glucometer
|
40 minutes after beverage consumption
|
|
Blood Glucose
Time Frame: 50 minutes after beverage consumption
|
Blood glucose will be measured in milligrams per deciliter using a glucometer
|
50 minutes after beverage consumption
|
|
Blood Glucose
Time Frame: 60 minutes after beverage consumption
|
Blood glucose will be measured in milligrams per deciliter using a glucometer
|
60 minutes after beverage consumption
|
|
Blood Glucose
Time Frame: 75 minutes after beverage consumption
|
Blood glucose will be measured in milligrams per deciliter using a glucometer
|
75 minutes after beverage consumption
|
|
Blood Glucose
Time Frame: 90 minutes after beverage consumption
|
Blood glucose will be measured in milligrams per deciliter using a glucometer
|
90 minutes after beverage consumption
|
|
Mood and Digestive Questionnaire
Time Frame: 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.
|
0 minutes before beverage consumption
|
|
Mood and Digestive Questionnaire
Time Frame: 0 minutes after 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.
|
0 minutes after beverage consumption
|
|
Mood and Digestive Questionnaire
Time Frame: 60 minutes after 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.
|
60 minutes after beverage consumption
|
|
Mood and Digestive Questionnaire
Time Frame: 120 minutes after 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.scale
questionnaire with scale 0 (None) to 10 (Extreme) where higher scores for positive mood attributes being better outcome and higher scores for both negative mood attributes and digestive traits being worse.scale
questionnaire with scale 0 (None) to 10 (Extreme)
|
120 minutes after beverage consumption
|
|
Mood and Digestive Questionnaire
Time Frame: 180 minutes after 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.
|
180 minutes after beverage consumption
|
|
Mood and Digestive Questionnaire
Time Frame: 240 minutes after 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.
|
240 minutes after beverage consumption
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO-FY2026-164
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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