Safety and Tolerability of a Novel Amino-acid Based Hydra... | NCT05592951

Status Module

Name	Class
Unilever R&D	INDUSTRY

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Crystal Light (once serving)	Dietary Supplement	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Alanine transaminase	Alanine transaminase measured as part of metabolic panel with units IU/L	baseline
Alanine transaminase	Alanine transaminase measured as part of metabolic panel with units IU/L	2 weeks of assigned treatment
Alanine transaminase	Alanine transaminase measured as part of metabolic panel with units IU/L	4 weeks of assigned treatment
Aspartate transferase	Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L	baseline
Aspartate transferase	Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L	2 weeks of assigned treatment
Aspartate transferase	Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L	4 weeks of assigned treatment
Albumin	Albumin measured as part of comprehensive metabolic panel with units g/dL	baseline
Albumin	Albumin measured as part of comprehensive metabolic panel with units g/dL

Eligibility Module

Contacts/Locations Module