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

NCT ID: NCT03559101

Last Updated: 2018-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-25
• Study Completion Date: 2017-12-18

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.

Conditions

Dehydration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Beverage 1 - Control

Distilled Water

Group Type: ACTIVE_COMPARATOR

Distilled water

Intervention Type: OTHER

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

Beverage 2

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

Group Type: EXPERIMENTAL

Medical Food 1

Intervention Type: OTHER

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

Beverage 3

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

Group Type: EXPERIMENTAL

Medical Food 2

Intervention Type: OTHER

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

Beverage 4

Pedialyte

Group Type: EXPERIMENTAL

Pedialyte

Intervention Type: OTHER

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

Beverage 5

Gatorade

Group Type: EXPERIMENTAL

Gatorade

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

W. Larry Kenney

OTHER

Sponsor Role: lead

Responsible Party

W. Larry Kenney

Professor of Physiology and Kinesiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

William L Kenney, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Pennsylvania State University

University Park, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31051498 (View on PubMed)

Other Identifiers

STUDY6412

Identifier Type: -

Identifier Source: org_study_id