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Recruiting NCT07507344

Beverage Hydration Index of Different Solutions

No phase Interventional Hydration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydramin hydration solution, Carbohydrate and Electrolyte hydration solution, Water.
Who it may be relevant to
Registry conditions: Hydration. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of the Beverage Hydration Index of Different Solutions

Overview

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 supplement Hydramin 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 supplement Carbohydrate 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 supplement Water
    1 L Smart Water

Primary outcome measures

  • Beverage Hydration Index [Time frame: 0 minutes after beverage consumption]
  • Beverage Hydration Index [Time frame: 60 minutes after beverage consumption]
  • Beverage Hydration Index [Time frame: 120 minutes after beverage consumption]
  • Beverage Hydration Index [Time frame: 180 minutes after beverage consumption]
  • Beverage Hydration Index [Time frame: 240 minutes after beverage consumption]
  • Net Fluid Balance [Time frame: 0 minutes after beverage consumption]
  • Net Fluid Balance [Time frame: 60 minutes after beverage consumption]
  • Net Fluid Balance [Time frame: 120 minutes after beverage consumption]
  • Net Fluid Balance [Time frame: 180 minutes after beverage consumption]
  • Net Fluid Balance [Time frame: 240 minutes after beverage consumption]
Secondary outcome measures (12)
  • Mood and Digestive Questionnaire [Time frame: 0 minutes before beverage consumption]
  • Mood and Digestive Questionnaire [Time frame: 0 minutes after beverage consumption]
  • Mood and Digestive Questionnaire [Time frame: 60 minutes after beverage consumption]
  • Mood and Digestive Questionnaire [Time frame: 120 minutes after beverage consumption]
  • Mood and Digestive Questionnaire [Time frame: 180 minutes after beverage consumption]
  • Mood and Digestive Questionnaire [Time frame: 240 minutes after beverage consumption]
  • Diastolic Blood Pressure [Time frame: 0 minutes before beverage consumption]
  • Diastolic Blood Pressure [Time frame: 0 minutes after beverage consumption]
  • Diastolic Blood Pressure [Time frame: 60 minutes after beverage consumption]
  • Diastolic Blood Pressure [Time frame: 120 minutes after beverage consumption]
  • Diastolic Blood Pressure [Time frame: 180 minutes after beverage consumption]
  • Diastolic Blood Pressure [Time frame: 240 minutes after beverage consumption]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Center for Nutraceutical and Dietary Supplement Research — Memphis

Identifiers

NCT: NCT07507344 · PRO-FY2026-164

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗