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

NCT03559101 | Completed

• 1 other identifier: STUDY6412
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Dehydration

Keywords

Hydration; Plasma Volume; Amino acids; Glucose; Electrolytes; Fluid Retention; Aging; Beverage Hydration Index; Dehydration; Oral Rehydration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Body Mass

  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

  Baseline before consumption of beverage and then 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption

Study Arms (5)

Beverage 1 - Control

ACTIVE COMPARATOR

Distilled Water

Other: Distilled water

Beverage 2

EXPERIMENTAL

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

Other: Medical Food 1

Beverage 3

EXPERIMENTAL

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

Other: Medical Food 2

Beverage 4

EXPERIMENTAL

Pedialyte

Other: Pedialyte

Beverage 5

EXPERIMENTAL

Gatorade

Other: Gatorade

Interventions

Distilled water 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 1 - Control

Medical Food 1 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 2 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

Pedialyte 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

Gatorade 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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or ≥60 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• W. Larry Kenney: lead

Study Sites (1)

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

• 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.

  PMID: 31051498 DERIVED

MeSH Terms

Conditions

Dehydration

Interventions

gatorade

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William L Kenney, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Physiology and Kinesiology

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 15, 2018
• Study Start: May 25, 2017
• Primary Completion: December 18, 2017
• Study Completion: December 18, 2017
• Last Updated: June 15, 2018

Record last verified: 2018-06

Locations

US (1)