Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers
Condition: Safety; Tolerance
Study type: Interventional

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.
    

Intervention name(s): Crystal Light (once serving); Liquid IV with amino acids (one serving); Liquid IV with amino acids (two servings); Liquid IV with amino acids (three servings)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Citric Acid, Potassium Citrate, Sodium Citrate, Aspartame (Phenylketonurics: Contains Phenylalanine), Magnesium Oxide, Maltodextrin, Contains Less than 2% of Natural Flavor, Acesulfame Potassium, Soy Lecithin, Yellow 5, Artificial Color.; Allulose, L-Alanine, L-Glutamine, Citric Acid, Sodium chloride, Lemon Lime Flavorings, Potassium Citrate, Trisodium Citrate Dihydrate, Dipotassium Phosphate, Syloid Silicon Dioxide, Stevia, Vitamin C, Vitamin B3, Calcium Pantothenate B5 (Vitamin B5), Vitamin B6, Vitamin B12. Liquid IV packets contain: sodium and potassium.; Allulose, L-Alanine, L-Glutamine, Citric Acid, Sodium chloride, Lemon Lime Flavorings, Potassium Citrate, Trisodium Citrate Dihydrate, Dipotassium Phosphate, Syloid Silicon Dioxide, Stevia, Vitamin C, Vitamin B3, Calcium Pantothenate B5 (Vitamin B5), Vitamin B6, Vitamin B12. Liquid IV packets contain: sodium and potassium.; Allulose, L-Alanine, L-Glutamine, Citric Acid, Sodium chloride, Lemon Lime Flavorings, Potassium Citrate, Trisodium Citrate Dihydrate, Dipotassium Phosphate, Syloid Silicon Dioxide, Stevia, Vitamin C, Vitamin B3, Calcium Pantothenate B5 (Vitamin B5), Vitamin B6, Vitamin B12. Liquid IV packets contain: sodium and potassium.
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo controlled study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Liquid IV; amino acids; electrolytes