Beverage Hydration Index of Different Solutions

Официальное название

Comparison of the Beverage Hydration Index of Different Solutions

Обзор

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.

Вмешательства

• Пищевая добавка 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)
• Пищевая добавка 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
• Пищевая добавка Water
  1 L Smart Water

Первичные конечные точки

• Beverage Hydration Index [Срок оценки: 0 minutes after beverage consumption]
• Beverage Hydration Index [Срок оценки: 60 minutes after beverage consumption]
• Beverage Hydration Index [Срок оценки: 120 minutes after beverage consumption]
• Beverage Hydration Index [Срок оценки: 180 minutes after beverage consumption]
• Beverage Hydration Index [Срок оценки: 240 minutes after beverage consumption]
• Net Fluid Balance [Срок оценки: 0 minutes after beverage consumption]
• Net Fluid Balance [Срок оценки: 60 minutes after beverage consumption]
• Net Fluid Balance [Срок оценки: 120 minutes after beverage consumption]
• Net Fluid Balance [Срок оценки: 180 minutes after beverage consumption]
• Net Fluid Balance [Срок оценки: 240 minutes after beverage consumption]

Вторичные конечные точки (12)

• Mood and Digestive Questionnaire [Срок оценки: 0 minutes before beverage consumption]
• Mood and Digestive Questionnaire [Срок оценки: 0 minutes after beverage consumption]
• Mood and Digestive Questionnaire [Срок оценки: 60 minutes after beverage consumption]
• Mood and Digestive Questionnaire [Срок оценки: 120 minutes after beverage consumption]
• Mood and Digestive Questionnaire [Срок оценки: 180 minutes after beverage consumption]
• Mood and Digestive Questionnaire [Срок оценки: 240 minutes after beverage consumption]
• Diastolic Blood Pressure [Срок оценки: 0 minutes before beverage consumption]
• Diastolic Blood Pressure [Срок оценки: 0 minutes after beverage consumption]
• Diastolic Blood Pressure [Срок оценки: 60 minutes after beverage consumption]
• Diastolic Blood Pressure [Срок оценки: 120 minutes after beverage consumption]
• Diastolic Blood Pressure [Срок оценки: 180 minutes after beverage consumption]
• Diastolic Blood Pressure [Срок оценки: 240 minutes after beverage consumption]

Критерии участия

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Center for Nutraceutical and Dietary Supplement Research — Memphis

Идентификаторы

NCT: NCT07507344 · PRO-FY2026-164

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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