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

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.

Conditions

• Safety
• Tolerance

Interventions

DIETARY_SUPPLEMENT

Crystal Light (once serving)

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.

DIETARY_SUPPLEMENT

Liquid IV with amino acids (one serving)

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.

DIETARY_SUPPLEMENT

Liquid IV with amino acids (two servings)

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.

DIETARY_SUPPLEMENT

Liquid IV with amino acids (three servings)

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.

Sponsors & Collaborators

• Unilever R&D

  collaborator INDUSTRY

• University of Memphis

  lead OTHER

Principal Investigators

• Richard Bloomer, PhD · University of Memphis

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-30

Primary Completion

2023-07-14

Completion

2023-07-18

Countries

• United States

Study Locations