Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers

Not Applicable

Completed

• Conditions: Tolerance; Safety
• Interventions: Dietary Supplement: Crystal Light (once serving); Dietary Supplement: Liquid IV with amino acids (three servings); Dietary Supplement: Liquid IV with amino acids (one serving); Dietary Supplement: Liquid IV with amino acids (two servings)

• Registration Number: NCT05592951
• Lead Sponsor: University of Memphis

Brief Summary

The nutrient composition of this product is similar to the existing Liquid IV "hydration multiplier" product already on the market but with the addition of amino acids. With such low quantities of amino acids, in particular as compared to the amounts consumed in normal diets, there is no reason to believe that the product would cause any adverse outcomes. However, since no research has been done on the safety of regular consumption of this product, this study will evaluate the safety of the product with regards to routing blood chemistries and other variables. Specifically, standard testing will be performed including a measurement of vital signs, comprehensive metabolic panel, hematology panel, urinalysis, and quantification of triiodothyronine, thyroxine, and thyroid stimulating hormone. A questionnaire will also be used to assess product tolerability.

Detailed Description

Maintaining adequate hydration is essential to optimal health, as well as athletic performance. When individuals exercise (in particular in a warm environment), they can lose excessive amounts of fluids along with necessary electrolytes (e.g., sodium, potassium, chloride) through sweating. With dehydration, individuals may feel sluggish and can experience impaired physical performance.

The use of electrolytes (sodium in particular) has been used for decades to aid athlete hydration and has led to the development of various sport drinks (e.g., Gatorade, Powerade) -which also include small amounts of carbohydrate. The addition of amino acids to electrolyte solutions has previously been demonstrated to further increase the transport of water and sodium from the jejunum (small intestine). Separate research also showed an amino acid and electrolyte drink increased cellular hydration compared to flavored water and electrolyte only drinks. A 2019 study found that amino acids hydration increased beverage hydration index (BHI)-a measure of fluid balance following consumption of a beverage and was age dependent.

Amino acids supplementation has been popular for some time among athletes due to other potential performance benefits including changes to anabolic hormone levels, alterations to energy consumption, and mental endurance. Further, amino acids may reduce post-exercise muscle soreness and aid in recovery.

The electrolyte amino-acid test product is a powder provided in individual stick packs and contains L-Alanine and L-Glutamine as well as 5 essential vitamins including Vitamins B3, B5, B6, B12 and Vitamin C. It is gluten-, soy-, and dairy-free, and provides electrolytes well below the daily value. The daily value (DV) tells us how much a particular nutrient in a serving of a food product contributes to a daily diet, based on a standard 2000 calorie diet. Despite what the name suggests, this product is taken orally, not intravenously. Liquid IV packets contain: sodium (510 mg, 22%DV) and potassium (380 mg, 8%DV). These packets contain a small percentage of the needed total electrolytes but adequate amounts to replace lost electrolytes as a result of physical activity.

The nutrient composition of this product is similar to the existing Liquid IV "hydration multiplier" product already on the market but with the addition of amino acids. With such low quantities of amino acids, in particular as compared to the amounts consumed in normal diets, there is no reason to believe that the product would cause any adverse outcomes. However, since no research has been done on the safety of regular consumption of this product, this study will evaluate the safety of the product with regards to routing blood chemistries and other variables. Specifically, standard testing will be performed including a measurement of vital signs, comprehensive metabolic panel, hematology panel, urinalysis, and quantification of triiodothyronine, thyroxine, and thyroid stimulating hormone. A questionnaire will also be used to assess product tolerability.

Study Timeline

• Study Start: 2022-09-30
• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-25
• Primary Completion: 2023-07-14
• Study Completion: 2023-07-18
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Body mass index (BMI) between 18-29.9 kg/m2
• able to fast overnight

Exclusion Criteria

• tobacco user
• history of heart disease/cardiovascular disease
• hypertensive (140/90 mmHg or less)
• diabetes
• history of immune disorder
• history of kidney disease
• hepatic impairment or disease
• history of unstable thyroid
• abnormality or obstruction of the gastrointestinal tract precluding swallowing
• abnormal digestion conditions
• previously diagnosed major affective disorder
• psychiatric disorder that required hospitalization in prior year
• history of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening)
• no known sensitivity or allergy to any of the study products
• consumption of alcohol-containing beverages within 24 hours of testing
• consumption of caffeine-containing beverages within 24 hours of testing
• active infection or illness of any kind
• if female, lactating, pregnant, or planning to become pregnant during the study
• receipt or use of an investigational product in another research study or change in medication, dietary supplementation, or significant change in diet/exercise regimen within 28 days prior to baseline/visit 2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo once daily	Crystal Light (once serving)	1 stick pack dissolved in water once daily prior to breakfast
Test beverage three times daily	Liquid IV with amino acids (three servings)	3 stick packs dissolved in water, one packet at a time three times daily (after breakfast, lunch, and dinner)
Test beverage once daily	Liquid IV with amino acids (one serving)	1 stick pack dissolved in water once daily prior to breakfast
Test beverage twice daily	Liquid IV with amino acids (two servings)	2 stick packs dissolved in water, one packet at a time twice daily (after lunch and after dinner)

Primary Outcome Measures

Name	Time	Method
Alkaline phosphatase	4 weeks of assigned treatment	Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
chloride	4 weeks of assigned treatment	chloride as part of comprehensive metabolic panel with units mmol/L
potassium	4 weeks of assigned treatment	potassium as part of comprehensive metabolic panel with units mmol/L
sodium	4 weeks of assigned treatment	sodium as part of comprehensive metabolic panel with units mmol/L
Alanine transaminase	4 weeks of assigned treatment	Alanine transaminase measured as part of metabolic panel with units IU/L
Aspartate transferase	4 weeks of assigned treatment	Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
total bilirubin	4 weeks of assigned treatment	total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
blood urea nitrogen mg/dL	baseline	blood urea nitrogen as part of comprehensive metabolic panel with unite
blood urea nitrogen	4 weeks of assigned treatment	blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL
calcium	4 weeks of assigned treatment	calcium as part of comprehensive metabolic panel with units mg/dL
total protein as part of comprehensive metabolic panel with units g/dL	4 weeks of assigned treatment	total protein
total globulin	4 weeks of assigned treatment	total globulin as part of comprehensive metabolic panel with units g/dL
White blood cell distribution (absolute)	4 weeks of assigned treatment	absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel
Red cell distribution width	4 weeks of assigned treatment	red cell distribution width as part of complete blood count panel with differential test measured as percentage
platelet count	4 weeks of assigned treatment	platelet count per microliter as part of complete blood count panel with differential test
white cell count	4 weeks of assigned treatment	white cell count per microliter as part of complete blood count panel with differential test
Albumin	4 weeks of assigned treatment	Albumin measured as part of comprehensive metabolic panel with units g/dL
carbon dioxide	4 weeks of assigned treatment	carbon dioxide as part of comprehensive metabolic panel with units mmol/L
blood glucose	4 weeks of assigned treatment	glucose as part of comprehensive metabolic panel with units mg/dL
hemoglobin	4 weeks of assigned treatment	hemoglobin as part of complete blood count panel with differential test measured as g/dL
Thyroxine	4 weeks of assigned treatment	Thyroxine ug/dL measured in blood as ug/dL
Urine potential of hydrogen	4 weeks of assigned treatment	Urine potential of hydrogen (pH) as reported in complete urinalysis
Protein in urine	4 weeks of assigned treatment	Protein, if present, measured in urine in complete urinalysis
Ketones in urine	4 weeks of assigned treatment	Ketones, if present, measured in urine in complete urinalysis
White blood cell esterase in urine	4 weeks of assigned treatment	White blood cell esterase, if present, measured in urine
Hematocrit	4 weeks of assigned treatment	Hematocrit as part of complete blood count panel with differential test measured as percentage
estimated glomerular filtration rate calculation	4 weeks of assigned treatment	estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
creatinine	4 weeks of assigned treatment	creatinine as part of comprehensive metabolic panel with units mg/dL
albumin/globulin ratio	4 weeks of assigned treatment	albumin/globulin ratio as part of comprehensive metabolic panel
mean corpuscular hemoglobin concentration	4 weeks of assigned treatment	mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL
red cell count	4 weeks of assigned treatment	red cell count per microliter as part of complete blood count panel with differential test
Triiodothyronine	4 weeks of assigned treatment	Triiodothyronine measured in blood as ng/dL
urobilinogen in urine	4 weeks of assigned treatment	urobilinogen in urine measured in urinalysis as mg/dL
tolerability questionnaire	1 day before 4 week visit	Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
blood urea nitrogen/creatinine ratio	4 weeks of assigned treatment	blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
mean corpuscular volume	4 weeks of assigned treatment	mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
White blood cell distribution (percentage)	4 weeks of assigned treatment	percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.
thyroid stimulating hormone	4 weeks of assigned treatment	Thyroxine measured in blood as micro-IU/dL
Urine appearance	4 weeks of assigned treatment	Urine appearance as reported in complete urinalysis
Urine specific gravity	4 weeks of assigned treatment	Urine specific gravity as reported in complete urinalysis
Glucose in urine	4 weeks of assigned treatment	Glucose, if present, measured in urine in complete urinalysis
Urine nitrite	4 weeks of assigned treatment	nitrite, if present, measured in urine
Heart Rate	4 weeks of assigned treatment	Heart rate measured using an automated blood pressure machine
Urine Color	4 weeks of assigned treatment	Urine color as reported in complete urinalysis
Occult blood in urine	4 weeks of assigned treatment	Occult blood, if present, measured in urine in complete urinalysis
bilirubin in urine	4 weeks of assigned treatment	bilirubin, if present, measured in urine
Blood Pressure	4 weeks of assigned treatment	Systolic and Diastolic blood pressure measured using an automated blood pressure machine
Product Tolerability questionnaire (gastrointestinal)	4 weeks of assigned treatment	Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the past two weeks from 0 (None) to 10 (severe)
Product Tolerability questionnaire (consumption)	4 weeks of assigned treatment visit	Questionnaire that can be scored 1-5 (1 bad quality to 5 good quality): with answers of strongly agree, agree, neutral, disagree, and strongly agree for tastes pleasant, easy to drink, easy on stomach, would purchase, dissolves easily, too gritty, too sticky and excessively, mildly too much, optimal, mildly too little, and extremely lacking for sweet, sour, salty, bitter. Final question on after taste with answers of pleasant, ok, no taste, unpleasant, extremely unpleasant.
Daily food diary	1 day before 4 week visit	A list of all food and drink consumed that day

Trial Locations

Locations (1)

Center for Nutraceutical and Dietary Supplement Research; 🇺🇸 Memphis, Tennessee, United States