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Effects of Amino Acid/Electrolyte-based Beverages on Hydration Status

Primary Purpose

Dehydration

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Distilled water
Medical Food 1
Medical Food 2
Pedialyte
Gatorade
Sponsored by
W. Larry Kenney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dehydration focused on measuring Hydration, Plasma Volume, Amino acids, Glucose, Electrolytes, Fluid Retention, Aging, Beverage Hydration Index, Dehydration, Oral Rehydration

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-30 years or ≥60 years

Exclusion Criteria:

  • cardiovascular, renal, or digestive diseases
  • pregnancy
  • breastfeeding
  • smoking and/or use of nicotine-containing products
  • illegal/recreational drug use
  • medications that alter fluid balance (e.g., diuretics)
  • allergy to Latex
  • men with prostate issues that interfere with urination.

Sites / Locations

  • Pennsylvania State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Beverage 1 - Control

Beverage 2

Beverage 3

Beverage 4

Beverage 5

Arm Description

Distilled Water

Medical Food 1 (8 amino acids, 60 mmol/L Na, 20 mmol/L K + citrate, Cl)

Medical Food 2 (8 amino acids, 30 mmol/L Na, 10 mmol/L K + citrate, Cl)

Pedialyte

Gatorade

Outcomes

Primary Outcome Measures

Beverage hydration index (BHI)
Indicative of amount of fluid remaining in body four hours post consumption of beverage. Inversely related to amount of urine produced over 4 hours. Larger BHI number indicates better fluid retention and maintenance of plasma volume.

Secondary Outcome Measures

Body Mass
Body weight measured on scale
Urine Mass
Weight of urine produced

Full Information

First Posted
May 22, 2018
Last Updated
June 14, 2018
Sponsor
W. Larry Kenney
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1. Study Identification

Unique Protocol Identification Number
NCT03559101
Brief Title
Effects of Amino Acid/Electrolyte-based Beverages on Hydration Status
Official Title
Characterization of the Effects of Amino Acid/Electrolyte-based Beverages on Hydration Status in Young and Older Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 25, 2017 (Actual)
Primary Completion Date
December 18, 2017 (Actual)
Study Completion Date
December 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
W. Larry Kenney

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Older adults typically do not drink later in the day to avoid the necessity of interrupting sleep to urinate. Sometimes they also limit ingestion of fluids to avoid the need to urinate when engaged in certain activities such as traveling or attending an event. Therefore, beverages that have greater fluid retention in the body leading to a more sustained positive hydration status could be advantageous in such situations. The composition of a beverage as well as other factors such as volume ingested and metabolism of components can affect the retention of the fluid in the body. Age may be another factor. The beverage hydration index (BHI), first described in 2016, was used to indicate the hydration response to thirteen well-known beverages in young male adults. The current study assesses the BHI of four beverages and how that response is affected by age following the standardized protocol. The four beverages have been chosen for inclusion in this study because they have been used by older adults to prevent dehydration.
Detailed Description
Subjects sign an informed consent form and undergo a medical screening prior to participation. The screening includes a physical exam, anthropometry, chemical and lipid profiles, as well as measures of liver and renal function. The subjects are assigned to one of two groups based upon age. Subjects participate in five experimental trials, one for each of the five beverages. The beverages are commercially-available and contain ingredients that are generally recognized as safe (GRAS). The order of the beverages is randomized. The list of ingredients on the bottle containing the beverage is obscured. The trials are identical and separated by at least five days. For each experiment, baseline measurements are conducted. Then the subjects consume one liter of the test beverage over thirty minutes. Additional measurements are performed thirty minutes post ingestion and then every hour for four hours post ingestion. This study yields two BHI numbers for each beverage, one number for each study-group. The BHI numbers are indicative of the amount of fluid remaining in the body four hours after consumption of the beverage. The BHI number is inversely related to the amount of urine produced over the four hours. A greater BHI number indicates better fluid retention and maintenance of plasma volume.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration
Keywords
Hydration, Plasma Volume, Amino acids, Glucose, Electrolytes, Fluid Retention, Aging, Beverage Hydration Index, Dehydration, Oral Rehydration

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Two groups of subjects (young, older) participate in five experiments, one for each of five beverage pretreatments. Pretreatments are consumed immediately prior to the experiment. The experiments are conducted in randomized order. The trials are identical and separated by at least five days.
Masking
InvestigatorOutcomes Assessor
Masking Description
The ingredients-list is masked on the bottles of beverage. Test beverages are coded. The research nurse logs the code, administers the test beverage, and discards the empty bottle prior to the experiment and in the absence of the investigator and outcomes assessor. The investigator and outcomes assessor do not have access to the log. Subjects do not discuss the beverages with the investigator and outcomes assessor.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beverage 1 - Control
Arm Type
Active Comparator
Arm Description
Distilled Water
Arm Title
Beverage 2
Arm Type
Experimental
Arm Description
Medical Food 1 (8 amino acids, 60 mmol/L Na, 20 mmol/L K + citrate, Cl)
Arm Title
Beverage 3
Arm Type
Experimental
Arm Description
Medical Food 2 (8 amino acids, 30 mmol/L Na, 10 mmol/L K + citrate, Cl)
Arm Title
Beverage 4
Arm Type
Experimental
Arm Description
Pedialyte
Arm Title
Beverage 5
Arm Type
Experimental
Arm Description
Gatorade
Intervention Type
Other
Intervention Name(s)
Distilled water
Intervention Description
Commercially available beverage Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption
Intervention Type
Other
Intervention Name(s)
Medical Food 1
Intervention Description
Commercially available beverage Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption
Intervention Type
Other
Intervention Name(s)
Medical Food 2
Intervention Description
Commercially available beverage Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption
Intervention Type
Other
Intervention Name(s)
Pedialyte
Intervention Description
Commercially available beverage Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption
Intervention Type
Other
Intervention Name(s)
Gatorade
Intervention Description
Commercially available beverage Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption
Primary Outcome Measure Information:
Title
Beverage hydration index (BHI)
Description
Indicative of amount of fluid remaining in body four hours post consumption of beverage. Inversely related to amount of urine produced over 4 hours. Larger BHI number indicates better fluid retention and maintenance of plasma volume.
Time Frame
One BHI for each beverage for each age group is calculated and reported through study completion, an average of 1 year.
Secondary Outcome Measure Information:
Title
Body Mass
Description
Body weight measured on scale
Time Frame
Baseline before consumption of beverage and then 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption
Title
Urine Mass
Description
Weight of urine produced
Time Frame
Baseline before consumption of beverage and then 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-30 years or ≥60 years Exclusion Criteria: cardiovascular, renal, or digestive diseases pregnancy breastfeeding smoking and/or use of nicotine-containing products illegal/recreational drug use medications that alter fluid balance (e.g., diuretics) allergy to Latex men with prostate issues that interfere with urination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William L Kenney, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31051498
Citation
Clarke MM, Stanhewicz AE, Wolf ST, Cheuvront SN, Kenefick RW, Kenney WL. A randomized trial to assess beverage hydration index in healthy older adults. Am J Clin Nutr. 2019 Jun 1;109(6):1640-1647. doi: 10.1093/ajcn/nqz009.
Results Reference
derived

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Effects of Amino Acid/Electrolyte-based Beverages on Hydration Status

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