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临床试验/NCT06733532
NCT06733532已完成不适用

Comparison of the Beverage Hydration Index of Different Solutions

University of Memphis2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2024年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Beverage Hydration Index

研究概览

简要总结

The present study will assess the effects of two different hydration solutions compared to water on hydration measures. It will follow the same approach as used by Maughan and colleagues (2016) to measure the fluid balance (the difference between the amount of water consumed and passed as urine) and beverage hydration index (the relative amount of urine passed after consumption of a drink compared to water) including time in positive fluid balance. Additionally, hydration status will be assessed with mood and digestive health questionnaires and blood pressure urine electrolyte concentrations, specific gravity, and osmolality determinations. The two oral rehydration solutions (Berry Propel Fitness Water and Essentia Hydroboost Raspberry Pomegranate) will be compared to the control (Smart Water). The purpose is to assess whether the changes in beverage composition improve the BHI above water alone for both treatments, with an hypothesized greater improvement in BHI observed with the Essentia Hydroboost Raspberry Pomegranate, due to the addition of carbohydrate.

详细描述

The present study will assess the effects of two different hydration solutions compared to water on hydration measures. It will follow the same approach as used by Maughan and colleagues (2016) to measure the fluid balance (the difference between the amount of water consumed and passed as urine) and beverage hydration index (the relative amount of urine passed after consumption of a drink compared to water) including time in positive fluid balance. Additionally, hydration status will be assessed with mood and digestive health questionnaires and blood pressure urine electrolyte concentrations, specific gravity, and osmolality determinations. The two oral rehydration solutions (Berry Propel Fitness Water and Essentia Hydroboost Raspberry Pomegranate) will be compared to the control (Smart Water). The purpose is to assess whether the changes in beverage composition improve the BHI above water alone for both treatments, with an hypothesized greater improvement in BHI observed with the Essentia Hydroboost Raspberry Pomegranate, due to the addition of carbohydrate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

treatments labeled A-C. Subjects will be provided the beverage in plastic cups without product labels

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • body mass index (BMI) <35 kg/m2 (not morbidly obese)
  • Cannot have a sensitivity or be allergic to any components of the study product they will be excluded.
  • non-tobacco user
  • cannot be following a specialized dietary pattern that may alter findings (e.g., low carbohydrate/ketogenic diet, carnivore diet, intermittent fasting etc.)
  • willing to replicate the same dietary intake/activity (exercise) level for each day before a lab visit excluding screening
  • Will consume a minimum of 2 liters (women) or 2.5 liters (men) of water per day, on each day prior to experimental lab visits (excluding screening)
  • Will arrive to lab for visits euhydrated (USG 1.005-1.020)
  • Will not consume alcohol-containing beverages within 24 hours of testing
  • Will not consume caffeine-containing beverages within 12 hours of testing
  • can fast (consume water/treatments only) for 15 hours (10 hours prior to lab visits not including screening)
  • avoid strenuous activity for 24 hours prior to study visits excluding screening
  • Will 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)
  • Will not have other conditions that is likely to alter fluid balance or be negatively affected by changing electrolyte levels/hydration status (as determined by Nurse practitioner)
  • Is not consuming any medication which may alter fluid retention/electrolyte levels such as sodium-glucose co-transporter 2 (SGLT2) inhibitor (for type 2 diabetes), laxatives, diuretics, Apremilast, chemotherapy, or lithium. (Medications will be reviewed by Nurse practitioner)
  • Will not consume nutritional supplements, performance enhancing drugs, and/or non-steroidal anti-inflammatory drugs within 7 days of study visits excluding screening.
  • cannot be enrolled in another clinical study within 30 days of the first study visit
  • without active infection or illness of any kind

排除标准

  • 未提供

结局指标

主要结局

Beverage Hydration Index

时间窗: 240 minutes after beverage consumption

Beverage Hydration Index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment

次要结局

  • Net Fluid Balance(240 minutes after beverage consumption)
  • Urine Osmolality(240 minutes after beverage consumption)
  • Urine Sodium(240 minutes after beverage consumption)
  • Urine Potassium(240 minutes after beverage consumption)
  • Urine Specific Gravity(240 minutes after beverage consumption)
  • Body Mass(240 minutes after beverage consumption)
  • Mood and Digestive Questionnaire(240 minutes after beverage consumption)
  • Diastolic Blood Pressure(240 minutes after beverage consumption)
  • Systolic Blood Pressure(240 minutes after beverage consumption)
  • Heart Rate(240 minutes after beverage consumption)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Bloomer

Dean of the College of Health Sciences

University of Memphis

研究点 (2)

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