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

W. Larry Kenney

Status: Completed

Conditions: Dehydration

Treatments: Other: Medical Food 2; Other: Distilled water; Other: Medical Food 1; Other: Pedialyte; Other: Gatorade

Study type: Interventional

Funder types: Other

Identifiers

NCT03559101

STUDY6412

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 5 patient groups

Beverage 1 - Control

Active Comparator group

Description:

Distilled Water

Treatment:

Other: Distilled water

Beverage 2

Experimental group

Description:

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

Treatment:

Other: Medical Food 1

Beverage 3

Experimental group

Description:

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

Treatment:

Other: Medical Food 2

Beverage 4

Experimental group

Description:

Pedialyte

Treatment:

Other: Pedialyte

Beverage 5

Experimental group

Description:

Gatorade

Treatment:

Other: Gatorade