Beverage Hydration Index of Different Solutions

NCT07507344 | Recruiting

• 1 other identifier: PRO-FY2026-164
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 BHI 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.

Conditions

Hydration

Keywords

hydration; electrolytes; Hydroamin; Beverage Hydration Index

Outcome Measures

Primary Outcomes (33)

• 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

  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

Secondary Outcomes (30)

• Mood and Digestive Questionnaire

  0 minutes before beverage consumption

• Mood and Digestive Questionnaire

  0 minutes after beverage consumption

• Mood and Digestive Questionnaire

  60 minutes after beverage consumption

• Mood and Digestive Questionnaire

  120 minutes after beverage consumption

• Mood and Digestive Questionnaire

  180 minutes after beverage consumption

Study Arms (6)

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

Dietary Supplement: Hyddramin hydration solution; Dietary Supplement: Carbohydrate and Electrolyte hydration solution; Dietary Supplement: 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

Dietary Supplement: Hyddramin hydration solution; Dietary Supplement: Carbohydrate and Electrolyte hydration solution; Dietary Supplement: Water

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

Dietary Supplement: Hyddramin hydration solution; Dietary Supplement: Carbohydrate and Electrolyte hydration solution; Dietary Supplement: Water

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

Dietary Supplement: Hyddramin hydration solution; Dietary Supplement: Carbohydrate and Electrolyte hydration solution; Dietary Supplement: Water

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

Dietary Supplement: Hyddramin hydration solution; Dietary Supplement: Carbohydrate and Electrolyte hydration solution; Dietary Supplement: Water

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

Dietary Supplement: Hyddramin hydration solution; Dietary Supplement: Carbohydrate and Electrolyte hydration solution; Dietary Supplement: Water

Interventions

Hyddramin 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)

Electrolyte and Carbohydrate, Hydramin, Water; Electrolyte and Carbohydrate, Water, Hydramin; Hydramin, Electrolyte and Carbohydrate, Water; Hydramin, Water, Electrolyte and Carbohydrate; Water, Electrolyte and Carbohydrate, Hydramin; Water, Hydramin, Electrolyte and Carbohydrate

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

Electrolyte and Carbohydrate, Hydramin, Water; Electrolyte and Carbohydrate, Water, Hydramin; Hydramin, Electrolyte and Carbohydrate, Water; Hydramin, Water, Electrolyte and Carbohydrate; Water, Electrolyte and Carbohydrate, Hydramin; Water, Hydramin, Electrolyte and Carbohydrate

Water DIETARY_SUPPLEMENT

1 L Smart Water

Electrolyte and Carbohydrate, Hydramin, Water; Electrolyte and Carbohydrate, Water, Hydramin; Hydramin, Electrolyte and Carbohydrate, Water; Hydramin, Water, Electrolyte and Carbohydrate; Water, Electrolyte and Carbohydrate, Hydramin; Water, Hydramin, Electrolyte and Carbohydrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

* 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 SSRIs (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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Memphis: lead
• PharmaLinea Ltd.: collaborator

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

RECRUITING

MeSH Terms

Interventions

Carbohydrates; Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Central Study Contacts

Jacquelyn Pence, PhD

CONTACT

901-678-1547; jpence1@memphis.edu

Richard Bloomer, PhD

CONTACT

rbloomer@memphis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Treatments will be assigned letters (A, B, C) and be provided to subjects in liquid form in opaque cups.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the College of Health Sciences

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-02

Locations

US (1)