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

Characterization of the Effects of Amino Acid/Electrolyte-based Beverages on Hydration Status in Young and Older Subjects

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.

Study Overview

• Status: Completed
• Conditions: Dehydration
• Intervention / Treatment: Other: Distilled water; Other: Medical Food 1; Other: Medical Food 2; Other: Pedialyte; Other: Gatorade

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Beverage 1 - Control; Distilled Water	Other: Distilled water; 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
Experimental: Beverage 2; Medical Food 1 (8 amino acids, 60 mmol/L Na, 20 mmol/L K + citrate, Cl)	Other: Medical Food 1; 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
Experimental: Beverage 3; Medical Food 2 (8 amino acids, 30 mmol/L Na, 10 mmol/L K + citrate, Cl)	Other: Medical Food 2; 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
Experimental: Beverage 4; Pedialyte	Other: Pedialyte; 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
Experimental: Beverage 5; Gatorade	Other: Gatorade; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One BHI for each beverage for each age group is calculated and reported through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass	Body weight measured on scale	Baseline before consumption of beverage and then 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption
Urine Mass	Weight of urine produced	Baseline before consumption of beverage and then 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption

Collaborators and Investigators

• Sponsor: W. Larry Kenney
• Investigators: Principal Investigator: William L Kenney, PhD, Penn State University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2017
• Primary Completion (Actual): December 18, 2017
• Study Completion (Actual): December 18, 2017

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): June 15, 2018
• Last Update Submitted That Met QC Criteria: June 14, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Hydration; Dehydration; Aging; Glucose; Oral Rehydration; Fluid Retention; Amino acids; Plasma Volume; Electrolytes; Beverage Hydration Index
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: STUDY6412

Drug and device information, study documents

• 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