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| Name | Class |
|---|---|
| PharmaLinea Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydramin, Electrolyte and Carbohydrate, Water | Experimental | 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 |
|
| Hydramin, Water, Electrolyte and Carbohydrate | Experimental | 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 |
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| Electrolyte and Carbohydrate, Hydramin, Water | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydramin hydration solution | Dietary Supplement | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Beverage Hydration Index | 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 | 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 | 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 | 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 | 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 |
| Net Fluid Balance | Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed | 0 minutes after beverage consumption |
| Net Fluid Balance |
| Measure | Description | Time Frame |
|---|---|---|
| Mood and Digestive Questionnaire | 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 |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacquelyn Pence, PhD | Contact | 901-678-1547 | jpence1@memphis.edu | |
| Richard Bloomer, PhD | Contact | rbloomer@memphis.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Nutraceutical and Dietary Supplement Research | Recruiting | Memphis | Tennessee | 38152 | United States |
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| ID | Term |
|---|---|
| D002241 | Carbohydrates |
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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Treatments will be assigned letters (A, B, C) and be provided to subjects in liquid form in opaque cups.
|
| Electrolyte and Carbohydrate, Water, Hydramin | Experimental | 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 |
|
| Water, Hydramin, Electrolyte and Carbohydrate | Experimental | 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 |
|
| Water, Electrolyte and Carbohydrate, Hydramin | Experimental | 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 |
|
| Carbohydrate and Electrolyte hydration solution | Dietary Supplement | 4 sticks of electrolyte and carbohydrate powder dissolved in 1 L Smart Water. Ingredients: Sodium, Chloride, Potassium, Magnesium, Vitamin C, Dextrose |
|
| Water | Dietary Supplement | 1 L Smart Water |
|
Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed
| 60 minutes after beverage consumption |
| Net Fluid Balance | Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed | 120 minutes after beverage consumption |
| Net Fluid Balance | Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed | 180 minutes after beverage consumption |
| Net Fluid Balance | Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed | 240 minutes after beverage consumption |
| Urine Specific Gravity | Urine Specific Gravity measured via refractometry. | 0 minutes before beverage consumption |
| Urine Specific Gravity | Urine Specific Gravity measured via refractometry. | 0 minutes after beverage consumption |
| Urine Specific Gravity | Urine Specific Gravity measured via refractometry. | 60 minutes after beverage consumption |
| Urine Specific Gravity | Urine Specific Gravity measured via refractometry. | 120 minutes after beverage consumption |
| Urine Specific Gravity | Urine Specific Gravity measured via refractometry. | 180 minutes after beverage consumption |
| Urine Specific Gravity | Urine Specific Gravity measured via refractometry. | 240 minutes after beverage consumption |
| Urine Sodium | Urine sodium will be measured in millimoles per kilogram of water | 0 minutes before beverage consumption |
| Urine Sodium | Urine sodium will be measured in milliosmoles per kilogram of water | 0 minutes after beverage consumption |
| Urine Sodium | Urine sodium will be measured in millimoles per kilogram of water | 60 minutes after beverage consumption |
| Urine Sodium | Urine sodium will be measured in milliosmoles per kilogram of water | 120 minutes after beverage consumption |
| Urine Sodium | Urine sodium will be measured in millimoles per kilogram of water | 180 minutes after beverage consumption |
| Urine Sodium | Urine sodium will be measured in millimoles per kilogram of water | 240 minutes after beverage consumption |
| Urine Potassium | Urine Potassium will be measured in millimoles per kilogram of water | 0 minutes before beverage consumption |
| Urine Potassium | Urine Potassium will be measured in millimoles per kilogram of water | 0 minutes after beverage consumption |
| Urine Potassium | Urine Potassium will be measured in millimoles per kilogram of water | 60 minutes after beverage consumption |
| Urine Potassium | Urine Potassium will be measured in millimoles per kilogram of water | 120 minutes after beverage consumption |
| Urine Potassium | Urine Potassium will be measured in millimoles per kilogram of water | 180 minutes after beverage consumption |
| Urine Potassium | Urine Potassium will be measured in millimoles per kilogram of water | 240 minutes after beverage consumption |
| Body mass | Body Mass in kilograms will be measured using a digital scale | 0 minutes before beverage consumption |
| Body mass | Body Mass in kilograms will be measured using a digital scale | 240 minutes after beverage consumption |
| Body Water | Body water will be determined using a digital bioelectrical impedance analysis scale. | 0 minutes before beverage consumption |
| Body Water | Body water will be determined using a digital bioelectrical impedance analysis scale. | 120 minutes after beverage consumption |
| Body Water | Body water will be determined using a digital bioelectrical impedance analysis scale. | 240 minutes after beverage consumption |
| Mood and Digestive Questionnaire | 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 | 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 | 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 | 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 | 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 |
| Diastolic Blood Pressure | Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff | 0 minutes before beverage consumption |
| Diastolic Blood Pressure | Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff | 0 minutes after beverage consumption |
| Diastolic Blood Pressure | Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff | 60 minutes after beverage consumption |
| Diastolic Blood Pressure | Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff | 120 minutes after beverage consumption |
| Diastolic Blood Pressure | Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff | 180 minutes after beverage consumption |
| Diastolic Blood Pressure | Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff | 240 minutes after beverage consumption |
| Systolic Blood Pressure | Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff | 0 minutes before beverage consumption |
| Systolic Blood Pressure | Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff | 0 minutes after beverage consumption |
| Systolic Blood Pressure | Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff | 60 minutes after beverage consumption |
| Systolic Blood Pressure | Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff | 120 minutes after beverage consumption |
| Systolic Blood Pressure | Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff | 180 minutes after beverage consumption |
| Systolic Blood Pressure | Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff | 240 minutes after beverage consumption |
| Heart Rate | Heart rate will be measured in beats per minute using an automated cuff | 0 minutes before beverage consumption |
| Heart Rate | Heart rate will be measured in beats per minute using an automated cuff | 0 minutes after beverage consumption |
| Heart Rate | Heart rate will be measured in beats per minute using an automated cuff | 60 minutes after beverage consumption |
| Heart Rate | Heart rate will be measured in beats per minute using an automated cuff | 120 minutes after beverage consumption |
| Heart Rate | Heart rate will be measured in beats per minute using an automated cuff | 180 minutes after beverage consumption |
| Heart Rate | Heart rate will be measured in beats per minute using an automated cuff | 240 minutes after beverage consumption |
| Blood Glucose | Blood glucose will be measured in milligrams per deciliter using a glucometer | 0 minutes before beverage consumption |
| Blood Glucose | Blood glucose will be measured in milligrams per deciliter using a glucometer | 40 minutes after beverage consumption |
| Blood Glucose | Blood glucose will be measured in milligrams per deciliter using a glucometer | 50 minutes after beverage consumption |
| Blood Glucose | Blood glucose will be measured in milligrams per deciliter using a glucometer | 60 minutes after beverage consumption |
| Blood Glucose | Blood glucose will be measured in milligrams per deciliter using a glucometer | 75 minutes after beverage consumption |
| Blood Glucose | Blood glucose will be measured in milligrams per deciliter using a glucometer | 90 minutes after beverage consumption |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |