Clinical trial NCT05592951: Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers
Official title: Randomized Trial to Assess the Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety
Tolerance
Keywords: Liquid IV
amino acids
electrolytes
Lead sponsor: University of Memphis
Sponsor class: OTHER
Collaborators: name: Unilever R&D
First posted: 2022-10-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo controlled study
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Alanine transaminase
timeFrame: baseline
measure: Alanine transaminase
timeFrame: 2 weeks of assigned treatment
measure: Alanine transaminase
timeFrame: 4 weeks of assigned treatment
measure: Aspartate transferase
timeFrame: baseline
measure: Aspartate transferase
timeFrame: 2 weeks of assigned treatment
measure: Aspartate transferase
timeFrame: 4 weeks of assigned treatment
measure: Albumin
timeFrame: baseline
measure: Albumin
timeFrame: 2 weeks of assigned treatment
measure: Albumin
timeFrame: 4 weeks of assigned treatment
measure: Alkaline phosphatase
timeFrame: baseline
measure: Alkaline phosphatase
timeFrame: 2 weeks of assigned treatment
measure: Alkaline phosphatase
timeFrame: 4 weeks of assigned treatment
measure: total bilirubin
timeFrame: baseline
measure: total bilirubin
timeFrame: 2 weeks of assigned treatment
measure: total bilirubin
timeFrame: 4 weeks of assigned treatment
measure: blood urea nitrogen mg/dL
timeFrame: baseline
measure: blood urea nitrogen
timeFrame: 2 weeks of assigned treatment
measure: blood urea nitrogen
timeFrame: 4 weeks of assigned treatment
measure: calcium
timeFrame: baseline
measure: calcium
timeFrame: 2 weeks of assigned treatment
measure: calcium
timeFrame: 4 weeks of assigned treatment
measure: carbon dioxide
timeFrame: baseline
measure: carbon dioxide
timeFrame: 2 weeks of assigned treatment
measure: carbon dioxide
timeFrame: 4 weeks of assigned treatment
measure: chloride
timeFrame: baseline
measure: chloride
timeFrame: 2 weeks of assigned treatment
measure: chloride
timeFrame: 4 weeks of assigned treatment
measure: creatinine
timeFrame: baseline
measure: creatinine
timeFrame: 2 weeks of assigned treatment
measure: creatinine
timeFrame: 4 weeks of assigned treatment
measure: estimated glomerular filtration rate calculation
timeFrame: baseline
measure: estimated glomerular filtration rate calculation
timeFrame: 2 weeks of assigned treatment
measure: estimated glomerular filtration rate calculation
timeFrame: 4 weeks of assigned treatment
measure: blood glucose
timeFrame: baseline
measure: blood glucose
timeFrame: 2 weeks of assigned treatment
measure: blood glucose
timeFrame: 4 weeks of assigned treatment
measure: potassium
timeFrame: baseline
measure: potassium
timeFrame: 2 weeks of assigned treatment
measure: potassium
timeFrame: 4 weeks of assigned treatment
measure: total protein as part of comprehensive metabolic panel with units g/dL
timeFrame: baseline
measure: total protein as part of comprehensive metabolic panel with units g/dL
timeFrame: 2 weeks of assigned treatment
measure: total protein as part of comprehensive metabolic panel with units g/dL
timeFrame: 4 weeks of assigned treatment
measure: sodium
timeFrame: baseline
measure: sodium
timeFrame: 2 weeks of assigned treatment
measure: sodium
timeFrame: 4 weeks of assigned treatment
measure: total globulin
timeFrame: baseline
measure: total globulin
timeFrame: 2 weeks of assigned treatment
measure: total globulin
timeFrame: 4 weeks of assigned treatment
measure: albumin/globulin ratio
timeFrame: baseline
measure: albumin/globulin ratio
timeFrame: 2 weeks of assigned treatment
measure: albumin/globulin ratio
timeFrame: 4 weeks of assigned treatment
measure: blood urea nitrogen/creatinine ratio
timeFrame: baseline
measure: blood urea nitrogen/creatinine ratio
timeFrame: 2 weeks of assigned treatment
measure: blood urea nitrogen/creatinine ratio
timeFrame: 4 weeks of assigned treatment
measure: Hematocrit
timeFrame: baseline
measure: Hematocrit
timeFrame: 2 weeks of assigned treatment
measure: Hematocrit
timeFrame: 4 weeks of assigned treatment
measure: hemoglobin
timeFrame: baseline
measure: hemoglobin
timeFrame: 2 weeks of assigned treatment
measure: hemoglobin
timeFrame: 4 weeks of assigned treatment
measure: mean corpuscular volume
timeFrame: baseline
measure: mean corpuscular volume
timeFrame: 2 weeks of assigned treatment
measure: mean corpuscular volume
timeFrame: 4 weeks of assigned treatment
measure: mean corpuscular hemoglobin concentration
timeFrame: baseline
measure: mean corpuscular hemoglobin concentration
timeFrame: 2 weeks of assigned treatment
measure: mean corpuscular hemoglobin concentration
timeFrame: 4 weeks of assigned treatment
measure: White blood cell distribution (absolute)
timeFrame: baseline
measure: White blood cell distribution (absolute)
timeFrame: 2 weeks of assigned treatment
measure: White blood cell distribution (absolute)
timeFrame: 4 weeks of assigned treatment
measure: White blood cell distribution (percentage)
timeFrame: baseline
measure: White blood cell distribution (percentage)
timeFrame: 2 weeks of assigned treatment
measure: White blood cell distribution (percentage)
timeFrame: 4 weeks of assigned treatment
measure: Red cell distribution width
timeFrame: baseline
measure: Red cell distribution width
timeFrame: 2 weeks of assigned treatment
measure: Red cell distribution width
timeFrame: 4 weeks of assigned treatment
measure: platelet count
timeFrame: baseline
measure: platelet count
timeFrame: 2 weeks of assigned treatment
measure: platelet count
timeFrame: 4 weeks of assigned treatment
measure: red cell count
timeFrame: baseline
measure: red cell count
timeFrame: 2 weeks of assigned treatment
measure: red cell count
timeFrame: 4 weeks of assigned treatment
measure: white cell count
timeFrame: baseline
measure: white cell count
timeFrame: 2 weeks of assigned treatment
measure: white cell count
timeFrame: 4 weeks of assigned treatment
measure: Triiodothyronine
timeFrame: baseline
measure: Triiodothyronine
timeFrame: 2 weeks of assigned treatment
measure: Triiodothyronine
timeFrame: 4 weeks of assigned treatment
measure: Thyroxine
timeFrame: baseline
measure: Thyroxine
timeFrame: 2 weeks of assigned treatment
measure: Thyroxine
timeFrame: 4 weeks of assigned treatment
measure: thyroid stimulating hormone
timeFrame: baseline
measure: thyroid stimulating hormone
timeFrame: 2 weeks of assigned treatment
measure: thyroid stimulating hormone
timeFrame: 4 weeks of assigned treatment
measure: Urine Color
timeFrame: baseline
measure: Urine Color
timeFrame: 2 weeks of assigned treatment
measure: Urine Color
timeFrame: 4 weeks of assigned treatment
measure: Urine appearance
timeFrame: baseline
measure: Urine appearance
timeFrame: 2 weeks of assigned treatment
measure: Urine appearance
timeFrame: 4 weeks of assigned treatment
measure: Urine specific gravity
timeFrame: baseline
measure: Urine specific gravity
timeFrame: 2 weeks of assigned treatment
measure: Urine specific gravity
timeFrame: 4 weeks of assigned treatment
measure: Urine potential of hydrogen
timeFrame: baseline
measure: Urine potential of hydrogen
timeFrame: 2 weeks of assigned treatment
measure: Urine potential of hydrogen
timeFrame: 4 weeks of assigned treatment
measure: Protein in urine
timeFrame: baseline
measure: Protein in urine
timeFrame: 2 weeks of assigned treatment
measure: Protein in urine
timeFrame: 4 weeks of assigned treatment
measure: Glucose in urine
timeFrame: baseline
measure: Glucose in urine
timeFrame: 2 weeks of assigned treatment
measure: Glucose in urine
timeFrame: 4 weeks of assigned treatment
measure: Ketones in urine
timeFrame: baseline
measure: Ketones in urine
timeFrame: 2 weeks of assigned treatment
measure: Ketones in urine
timeFrame: 4 weeks of assigned treatment
measure: Occult blood in urine
timeFrame: baseline
measure: Occult blood in urine
timeFrame: 2 weeks of assigned treatment
measure: Occult blood in urine
timeFrame: 4 weeks of assigned treatment
measure: White blood cell esterase in urine
timeFrame: baseline
measure: White blood cell esterase in urine
timeFrame: 2 weeks of assigned treatment
measure: White blood cell esterase in urine
timeFrame: 4 weeks of assigned treatment
measure: Urine nitrite
timeFrame: baseline
measure: Urine nitrite
timeFrame: 2 weeks of assigned treatment
measure: Urine nitrite
timeFrame: 4 weeks of assigned treatment
measure: bilirubin in urine
timeFrame: baseline
measure: bilirubin in urine
timeFrame: 2 weeks of assigned treatment
measure: bilirubin in urine
timeFrame: 4 weeks of assigned treatment
measure: urobilinogen in urine
timeFrame: baseline
measure: urobilinogen in urine
timeFrame: 2 weeks of assigned treatment
measure: urobilinogen in urine
timeFrame: 4 weeks of assigned treatment
measure: Heart Rate
timeFrame: baseline
measure: Heart Rate
timeFrame: 2 weeks of assigned treatment
measure: Heart Rate
timeFrame: 4 weeks of assigned treatment
measure: Blood Pressure
timeFrame: baseline
measure: Blood Pressure
timeFrame: 2 weeks of assigned treatment
measure: Blood Pressure
timeFrame: 4 weeks of assigned treatment
measure: Product Tolerability questionnaire (gastrointestinal)
timeFrame: baseline
measure: Product Tolerability questionnaire (gastrointestinal)
timeFrame: 2 weeks of assigned treatment
measure: Product Tolerability questionnaire (gastrointestinal)
timeFrame: 4 weeks of assigned treatment
measure: Product Tolerability questionnaire (consumption)
timeFrame: baseline
measure: Product Tolerability questionnaire (consumption)
timeFrame: 2 weeks of assigned treatment
measure: Product Tolerability questionnaire (consumption)
timeFrame: 4 weeks of assigned treatment visit
measure: tolerability questionnaire
timeFrame: 3 days before baseline visit
measure: Daily food diary
timeFrame: 3 days before baseline visit
measure: tolerability questionnaire
timeFrame: 2 days before baseline visit
measure: Daily food diary
timeFrame: 2 days before baseline visit
measure: tolerability questionnaire
timeFrame: 1 day before baseline visit
measure: Daily food diary
timeFrame: 1 day before baseline visit
measure: tolerability questionnaire
timeFrame: 3 days before 2 week visit
measure: Daily food diary
timeFrame: 3 days before 2 week visit
measure: Daily food diary
timeFrame: 2 days before 2 week visit
measure: tolerability questionnaire
timeFrame: 2 days before 2 week visit
measure: tolerability questionnaire
timeFrame: 1 day before 2 week visit
measure: Daily food diary
timeFrame: 1 day before 2 week visit
measure: tolerability questionnaire
timeFrame: 3 days before 4 week visit
measure: Daily food diary
timeFrame: 3 days before 4 week visit
measure: tolerability questionnaire
timeFrame: 2 days before 4 week visit
measure: Daily food diary
timeFrame: 2 days before 4 week visit
measure: tolerability questionnaire
timeFrame: 1 day before 4 week visit
measure: Daily food diary
timeFrame: 1 day before 4 week visit
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Center for Nutraceutical and Dietary Supplement Research
state: Tennessee
Study officials:
affiliation: University of Memphis
name: Richard Bloomer, PhD
role: PRINCIPAL_INVESTIGATOR
References: