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临床试验/NCT05111392
NCT05111392已完成1 期

Hydration Dynamics and Influence of Beverage Composition

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年9月3日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
14
试验地点
2
主要终点
Rate of appearance of deuterium in the plasma for oral rehydration solution 2.

研究概览

简要总结

The study examines interactions between fluid availability in the gut and fluid retention in the body. The relative rate of fluid uptake, the expansion of the plasma volume, and percent of fluid retained by the body will be measured in response to ingestion of beverages of different composition. Healthy, euhydrated adults will be studied. The results will help establish formulations of beverages that sustain if not promote acute euhydration.

详细描述

Using a randomized order for beverage treatments at three separate trials, subjects will ingest 1 Liter of one of three beverages in 10 minutes: water, a beverage with 2.5% glucose with 45 mmol sodium/L, or a beverage with 1.7% glucose with 60 mmol sodium/L. Before and repeatedly for 2 h after ingestion of the beverage, blood samples will be drawn for assessments of D2O, Hb, Hct, osmolality, sodium, and glucose. The rate of appearance of D2O will be evaluated using the area under the curve, the slope of the appearance, and half time to plateau. Comparisons will be made between beverages for indices of the rate of appearance of D2O, the change in PV over time, and cumulative urine excreted. The cumulative urine produced will be used to calculate a modified BHI for the two glucose-electrolyte beverages and water for comparison with 1.0 (expected for no beverage effect). We hypothesize faster absorption (D2O appearance rate), and better overall hydration (expanded PV and higher modified BHI) will occur for beverages containing glucose and sodium compared to water. Further, we hypothesize that of the electrolyte beverages, the beverage with higher sodium content will promote greater overall hydration (less urine excreted) than the beverage with lower sodium.

研究设计

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

盲法说明

Beverages will have similar color, flavoring, and taste.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Have a BMI of 18.5 to 29.9 kg/m
  • Be normotensive (<120/80 mm Hg).
  • Must be able to speak and read English.
  • Be physically active or a regular exerciser but be able to abstain from exercise for 48 h prior to each study trial.
  • Fast for at least 8 hours prior to and through the study trial.
  • Be able to abstain from alcohol for 48 h prior to each study.
  • Be able to abstain from caffeine for 24 h prior to each study.
  • If female, must have regular menstrual cycles, that are > 27 days and < 35 days in length.

排除标准

  • Under 18 y of age or over 45 y of age.
  • Have a BMI <18.5 or >
  • Being pregnant.
  • Lactating.
  • Tobacco user.
  • Have hypotension or hypertension.
  • Have any type of kidney disease or dysfunction.
  • Have diabetes.
  • Have any type of cardiovascular disease.
  • Have been diagnosed with galactosemia.
  • Females with irregular menstrual cycles.
  • Females with polycystic ovary disease.

结局指标

主要结局

Rate of appearance of deuterium in the plasma for oral rehydration solution 2.

时间窗: 2 hours

Measure the rate of fluid uptake by the gut using appearance of deuterium oxide, or D2O, in the blood after ingesting a fixed volume of placebo.

Rate of appearance of deuterium in the plasma for oral rehydration solution 1.

时间窗: 2 hours

Measure the rate of fluid uptake by the gut using appearance of deuterium oxide, or D2O, in the blood after ingesting a fixed volume of placebo.

Rate of appearance of deuterium in the plasma for placebo

时间窗: 2 hours

Measure the rate of fluid uptake by the gut using appearance of deuterium oxide, or D2O, in the blood after ingesting a fixed volume of placebo.

次要结局

  • Change in plasma volume for oral rehydration solution 2(2 hours)
  • Fluid retention for oral rehydration solution 2(2 hours)
  • Change in plasma volume for placebo(2 hours)
  • Change in plasma volume for oral rehydration solution 1(2 hours)
  • Fluid retention for placebo(2 hours)
  • Fluid retention for oral rehydration solution 1(2 hours)

研究者

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

Craig A. Horswill

Clinical Associate Professor

University of Illinois at Chicago

研究点 (2)

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