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

Randomized Trial to Assess the Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers

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 Overview

• Status: Completed
• Conditions: Tolerance; Safety
• Intervention / Treatment: Dietary supplement: Crystal Light (once serving); Dietary supplement: Liquid IV with amino acids (one serving); Dietary supplement: Liquid IV with amino acids (two servings); Dietary supplement: Liquid IV with amino acids (three servings)

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38152
      • Center for Nutraceutical and Dietary Supplement Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo once daily; 1 stick pack dissolved in water once daily prior to breakfast	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.
Experimental: Test beverage once daily; 1 stick pack dissolved in water once daily prior to breakfast	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.
Experimental: Test beverage twice daily; 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); 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.
Experimental: Test beverage three times daily; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	2 weeks of assigned treatment
Albumin	Albumin measured as part of comprehensive metabolic panel with units g/dL	4 weeks of assigned treatment
Alkaline phosphatase	Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L	baseline
Alkaline phosphatase	Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L	2 weeks of assigned treatment
Alkaline phosphatase	Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L	4 weeks of assigned treatment
total bilirubin	total bilirubin measured as part of comprehensive metabolic panel with units mg/dL	baseline
total bilirubin	total bilirubin measured as part of comprehensive metabolic panel with units mg/dL	2 weeks of assigned treatment
total bilirubin	total bilirubin measured as part of comprehensive metabolic panel with units mg/dL	4 weeks of assigned treatment
blood urea nitrogen mg/dL	blood urea nitrogen as part of comprehensive metabolic panel with unite	baseline
blood urea nitrogen	blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL	2 weeks of assigned treatment
blood urea nitrogen	blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL	4 weeks of assigned treatment
calcium	calcium as part of comprehensive metabolic panel with units mg/dL	baseline
calcium	calcium as part of comprehensive metabolic panel with units mg/dL	2 weeks of assigned treatment
calcium	calcium as part of comprehensive metabolic panel with units mg/dL	4 weeks of assigned treatment
carbon dioxide	carbon dioxide as part of comprehensive metabolic panel with units mmol/L	baseline
carbon dioxide	carbon dioxide as part of comprehensive metabolic panel with units mmol/L	2 weeks of assigned treatment
carbon dioxide	carbon dioxide as part of comprehensive metabolic panel with units mmol/L	4 weeks of assigned treatment
chloride	chloride as part of comprehensive metabolic panel with units mmol/L	baseline
chloride	chloride as part of comprehensive metabolic panel with units mmol/L	2 weeks of assigned treatment
chloride	chloride as part of comprehensive metabolic panel with units mmol/L	4 weeks of assigned treatment
creatinine	creatinine as part of comprehensive metabolic panel with units mg/dL	baseline
creatinine	creatinine as part of comprehensive metabolic panel with units mg/dL	2 weeks of assigned treatment
creatinine	creatinine as part of comprehensive metabolic panel with units mg/dL	4 weeks of assigned treatment
estimated glomerular filtration rate calculation	estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73	baseline
estimated glomerular filtration rate calculation	estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73	2 weeks of assigned treatment
estimated glomerular filtration rate calculation	estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73	4 weeks of assigned treatment
blood glucose	glucose as part of comprehensive metabolic panel with units mg/dL	baseline
blood glucose	glucose as part of comprehensive metabolic panel with units mg/dL	2 weeks of assigned treatment
blood glucose	glucose as part of comprehensive metabolic panel with units mg/dL	4 weeks of assigned treatment
potassium	potassium as part of comprehensive metabolic panel with units mmol/L	baseline
potassium	potassium as part of comprehensive metabolic panel with units mmol/L	2 weeks of assigned treatment
potassium	potassium as part of comprehensive metabolic panel with units mmol/L	4 weeks of assigned treatment
total protein as part of comprehensive metabolic panel with units g/dL	total protein	baseline
total protein as part of comprehensive metabolic panel with units g/dL	total protein	2 weeks of assigned treatment
total protein as part of comprehensive metabolic panel with units g/dL	total protein	4 weeks of assigned treatment
sodium	sodium as part of comprehensive metabolic panel with units mmol/L	baseline
sodium	sodium as part of comprehensive metabolic panel with units mmol/L	2 weeks of assigned treatment
sodium	sodium as part of comprehensive metabolic panel with units mmol/L	4 weeks of assigned treatment
total globulin	total globulin as part of comprehensive metabolic panel with units g/dL	baseline
total globulin	total globulin as part of comprehensive metabolic panel with units g/dL	2 weeks of assigned treatment
total globulin	total globulin as part of comprehensive metabolic panel with units g/dL	4 weeks of assigned treatment
albumin/globulin ratio	albumin/globulin ratio as part of comprehensive metabolic panel	baseline
albumin/globulin ratio	albumin/globulin ratio as part of comprehensive metabolic panel	2 weeks of assigned treatment
albumin/globulin ratio	albumin/globulin ratio as part of comprehensive metabolic panel	4 weeks of assigned treatment
blood urea nitrogen/creatinine ratio	blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel	baseline
blood urea nitrogen/creatinine ratio	blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel	2 weeks of assigned treatment
blood urea nitrogen/creatinine ratio	blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel	4 weeks of assigned treatment
Hematocrit	Hematocrit as part of complete blood count panel with differential test measured as percentage	baseline
Hematocrit	Hematocrit as part of complete blood count panel with differential test measured as percentage	2 weeks of assigned treatment
Hematocrit	Hematocrit as part of complete blood count panel with differential test measured as percentage	4 weeks of assigned treatment
hemoglobin	hemoglobin as part of complete blood count panel with differential test measured as g/dL	baseline
hemoglobin	hemoglobin as part of complete blood count panel with differential test measured as g/dL	2 weeks of assigned treatment
hemoglobin	hemoglobin as part of complete blood count panel with differential test measured as g/dL	4 weeks of assigned treatment
mean corpuscular volume	mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter	baseline
mean corpuscular volume	mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter	2 weeks of assigned treatment
mean corpuscular volume	mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter	4 weeks of assigned treatment
mean corpuscular hemoglobin concentration	mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL	baseline
mean corpuscular hemoglobin concentration	mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL	2 weeks of assigned treatment
mean corpuscular hemoglobin concentration	mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL	4 weeks of assigned treatment
White blood cell distribution (absolute)	absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel	baseline
White blood cell distribution (absolute)	absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel	2 weeks of assigned treatment
White blood cell distribution (absolute)	absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel	4 weeks of assigned treatment
White blood cell distribution (percentage)	percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.	baseline
White blood cell distribution (percentage)	percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.	2 weeks of assigned treatment
White blood cell distribution (percentage)	percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.	4 weeks of assigned treatment
Red cell distribution width	red cell distribution width as part of complete blood count panel with differential test measured as percentage	baseline
Red cell distribution width	red cell distribution width as part of complete blood count panel with differential test measured as percentage	2 weeks of assigned treatment
Red cell distribution width	red cell distribution width as part of complete blood count panel with differential test measured as percentage	4 weeks of assigned treatment
platelet count	platelet count per microliter as part of complete blood count panel with differential test	baseline
platelet count	platelet count per microliter as part of complete blood count panel with differential test	2 weeks of assigned treatment
platelet count	platelet count per microliter as part of complete blood count panel with differential test	4 weeks of assigned treatment
red cell count	red cell count per microliter as part of complete blood count panel with differential test	baseline
red cell count	red cell count per microliter as part of complete blood count panel with differential test	2 weeks of assigned treatment
red cell count	red cell count per microliter as part of complete blood count panel with differential test	4 weeks of assigned treatment
white cell count	white cell count per microliter as part of complete blood count panel with differential test	baseline
white cell count	white cell count per microliter as part of complete blood count panel with differential test	2 weeks of assigned treatment
white cell count	white cell count per microliter as part of complete blood count panel with differential test	4 weeks of assigned treatment
Triiodothyronine	Triiodothyronine measured in blood as ng/dL	baseline
Triiodothyronine	Triiodothyronine measured in blood as ng/dL	2 weeks of assigned treatment
Triiodothyronine	Triiodothyronine measured in blood as ng/dL	4 weeks of assigned treatment
Thyroxine	Thyroxine measured in blood as ug/dL	baseline
Thyroxine	Thyroxine ug/dL measured in blood as ug/dL	2 weeks of assigned treatment
Thyroxine	Thyroxine ug/dL measured in blood as ug/dL	4 weeks of assigned treatment
thyroid stimulating hormone	Thyroxine measured in blood as micro-IU/dL	baseline
thyroid stimulating hormone	Thyroxine measured in blood as micro-IU/dL	2 weeks of assigned treatment
thyroid stimulating hormone	Thyroxine measured in blood as micro-IU/dL	4 weeks of assigned treatment
Urine Color	Urine color as reported in complete urinalysis	baseline
Urine Color	Urine color as reported in complete urinalysis	2 weeks of assigned treatment
Urine Color	Urine color as reported in complete urinalysis	4 weeks of assigned treatment
Urine appearance	Urine appearance as reported in complete urinalysis	baseline
Urine appearance	Urine appearance as reported in complete urinalysis	2 weeks of assigned treatment
Urine appearance	Urine appearance as reported in complete urinalysis	4 weeks of assigned treatment
Urine specific gravity	Urine specific gravity as reported in complete urinalysis	baseline
Urine specific gravity	Urine specific gravity as reported in complete urinalysis	2 weeks of assigned treatment
Urine specific gravity	Urine specific gravity as reported in complete urinalysis	4 weeks of assigned treatment
Urine potential of hydrogen	Urine potential of hydrogen (pH) as reported in complete urinalysis	baseline
Urine potential of hydrogen	Urine potential of hydrogen (pH) as reported in complete urinalysis	2 weeks of assigned treatment
Urine potential of hydrogen	Urine potential of hydrogen (pH) as reported in complete urinalysis	4 weeks of assigned treatment
Protein in urine	Protein, if present, measured in urine in complete urinalysis	baseline
Protein in urine	Protein, if present, measured in urine in complete urinalysis	2 weeks of assigned treatment
Protein in urine	Protein, if present, measured in urine in complete urinalysis	4 weeks of assigned treatment
Glucose in urine	Glucose, if present, measured in urine in complete urinalysis	baseline
Glucose in urine	Glucose, if present, measured in urine in complete urinalysis	2 weeks of assigned treatment
Glucose in urine	Glucose, if present, measured in urine in complete urinalysis	4 weeks of assigned treatment
Ketones in urine	Ketones, if present, measured in urine in complete urinalysis	baseline
Ketones in urine	Ketones, if present, measured in urine in complete urinalysis	2 weeks of assigned treatment
Ketones in urine	Ketones, if present, measured in urine in complete urinalysis	4 weeks of assigned treatment
Occult blood in urine	Occult blood, if present, measured in urine in complete urinalysis	baseline
Occult blood in urine	Occult blood, if present, measured in urine in complete urinalysis	2 weeks of assigned treatment
Occult blood in urine	Occult blood, if present, measured in urine in complete urinalysis	4 weeks of assigned treatment
White blood cell esterase in urine	White blood cell esterase, if present, measured in urine	baseline
White blood cell esterase in urine	White blood cell esterase, if present, measured in urine	2 weeks of assigned treatment
White blood cell esterase in urine	White blood cell esterase, if present, measured in urine	4 weeks of assigned treatment
Urine nitrite	nitrite, if present, measured in urine	baseline
Urine nitrite	nitrite, if present, measured in urine	2 weeks of assigned treatment
Urine nitrite	nitrite, if present, measured in urine	4 weeks of assigned treatment
bilirubin in urine	bilirubin, if present, measured in urine	baseline
bilirubin in urine	bilirubin, if present, measured in urine	2 weeks of assigned treatment
bilirubin in urine	bilirubin, if present, measured in urine	4 weeks of assigned treatment
urobilinogen in urine	urobilinogen in urine measured in urinalysis as mg/dL	baseline
urobilinogen in urine	urobilinogen in urine measured in urinalysis as mg/dL	2 weeks of assigned treatment
urobilinogen in urine	urobilinogen in urine measured in urinalysis as mg/dL	4 weeks of assigned treatment
Heart Rate	Heart Rate measured using an automated blood pressure machine	baseline
Heart Rate	Heart rate measured using an automated blood pressure machine	2 weeks of assigned treatment
Heart Rate	Heart rate measured using an automated blood pressure machine	4 weeks of assigned treatment
Blood Pressure	Systolic and Diastolic blood pressure measured using an automated blood pressure machine	baseline
Blood Pressure	Systolic and Diastolic blood pressure measured using an automated blood pressure machine	2 weeks of assigned treatment
Blood Pressure	Systolic and Diastolic blood pressure measured using an automated blood pressure machine	4 weeks of assigned treatment
Product Tolerability questionnaire (gastrointestinal)	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)	baseline
Product Tolerability questionnaire (gastrointestinal)	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)	2 weeks of assigned treatment
Product Tolerability questionnaire (gastrointestinal)	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)	4 weeks of assigned treatment
Product Tolerability questionnaire (consumption)	Questionnaire that can be scored 1-5 (1 bad quality to 5 good quality): 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.	baseline
Product Tolerability questionnaire (consumption)	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.	2 weeks of assigned treatment
Product Tolerability questionnaire (consumption)	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.	4 weeks of assigned treatment visit
tolerability questionnaire	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)	3 days before baseline visit
Daily food diary	A list of all food and drink consumed that day	3 days before baseline visit
tolerability questionnaire	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)	2 days before baseline visit
Daily food diary	A list of all food and drink consumed that day	2 days before baseline visit
tolerability questionnaire	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)	1 day before baseline visit
Daily food diary	A list of all food and drink consumed that day	1 day before baseline visit
tolerability questionnaire	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)	3 days before 2 week visit
Daily food diary	A list of all food and drink consumed that day	3 days before 2 week visit
Daily food diary	A list of all food and drink consumed that day	2 days before 2 week visit
tolerability questionnaire	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)	2 days before 2 week visit
tolerability questionnaire	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)	1 day before 2 week visit
Daily food diary	A list of all food and drink consumed that day	1 day before 2 week visit
tolerability questionnaire	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)	3 days before 4 week visit
Daily food diary	A list of all food and drink consumed that day	3 days before 4 week visit
tolerability questionnaire	A list of all food and drink consumed that day along with a 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)	2 days before 4 week visit
Daily food diary	A list of all food and drink consumed that day	2 days before 4 week visit
tolerability questionnaire	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)	1 day before 4 week visit
Daily food diary	A list of all food and drink consumed that day	1 day before 4 week visit

Collaborators and Investigators

• Sponsor: University of Memphis
• Collaborators: Unilever R&D
• Investigators: Principal Investigator: Richard Bloomer, PhD, University of Memphis

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): July 14, 2023
• Study Completion (Actual): July 18, 2023

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: amino acids; electrolytes; Liquid IV
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: PRO-FY2023-5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No