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

Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05592951
• Other study ID #: PRO-FY2023-5
• Status: Completed
• Phase: N/A
• Start date: September 30, 2022
• Est. completion date: July 18, 2023

Study information

• Verified date: September 2023
• Source: University of Memphis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 18, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Safety
• Tolerance

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Center for Nutraceutical and Dietary Supplement Research	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Memphis	Unilever R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alanine transaminase	Alanine transaminase measured as part of metabolic panel with units IU/L	baseline
Primary	Alanine transaminase	Alanine transaminase measured as part of metabolic panel with units IU/L	2 weeks of assigned treatment
Primary	Alanine transaminase	Alanine transaminase measured as part of metabolic panel with units IU/L	4 weeks of assigned treatment
Primary	Aspartate transferase	Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L	baseline
Primary	Aspartate transferase	Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L	2 weeks of assigned treatment
Primary	Aspartate transferase	Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L	4 weeks of assigned treatment
Primary	Albumin	Albumin measured as part of comprehensive metabolic panel with units g/dL	baseline
Primary	Albumin	Albumin measured as part of comprehensive metabolic panel with units g/dL	2 weeks of assigned treatment
Primary	Albumin	Albumin measured as part of comprehensive metabolic panel with units g/dL	4 weeks of assigned treatment
Primary	Alkaline phosphatase	Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L	baseline
Primary	Alkaline phosphatase	Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L	2 weeks of assigned treatment
Primary	Alkaline phosphatase	Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L	4 weeks of assigned treatment
Primary	total bilirubin	total bilirubin measured as part of comprehensive metabolic panel with units mg/dL	baseline
Primary	total bilirubin	total bilirubin measured as part of comprehensive metabolic panel with units mg/dL	2 weeks of assigned treatment
Primary	total bilirubin	total bilirubin measured as part of comprehensive metabolic panel with units mg/dL	4 weeks of assigned treatment
Primary	blood urea nitrogen mg/dL	blood urea nitrogen as part of comprehensive metabolic panel with unite	baseline
Primary	blood urea nitrogen	blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL	2 weeks of assigned treatment
Primary	blood urea nitrogen	blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL	4 weeks of assigned treatment
Primary	calcium	calcium as part of comprehensive metabolic panel with units mg/dL	baseline
Primary	calcium	calcium as part of comprehensive metabolic panel with units mg/dL	2 weeks of assigned treatment
Primary	calcium	calcium as part of comprehensive metabolic panel with units mg/dL	4 weeks of assigned treatment
Primary	carbon dioxide	carbon dioxide as part of comprehensive metabolic panel with units mmol/L	baseline
Primary	carbon dioxide	carbon dioxide as part of comprehensive metabolic panel with units mmol/L	2 weeks of assigned treatment
Primary	carbon dioxide	carbon dioxide as part of comprehensive metabolic panel with units mmol/L	4 weeks of assigned treatment
Primary	chloride	chloride as part of comprehensive metabolic panel with units mmol/L	baseline
Primary	chloride	chloride as part of comprehensive metabolic panel with units mmol/L	2 weeks of assigned treatment
Primary	chloride	chloride as part of comprehensive metabolic panel with units mmol/L	4 weeks of assigned treatment
Primary	creatinine	creatinine as part of comprehensive metabolic panel with units mg/dL	baseline
Primary	creatinine	creatinine as part of comprehensive metabolic panel with units mg/dL	2 weeks of assigned treatment
Primary	creatinine	creatinine as part of comprehensive metabolic panel with units mg/dL	4 weeks of assigned treatment
Primary	estimated glomerular filtration rate calculation	estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73	baseline
Primary	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
Primary	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
Primary	blood glucose	glucose as part of comprehensive metabolic panel with units mg/dL	baseline
Primary	blood glucose	glucose as part of comprehensive metabolic panel with units mg/dL	2 weeks of assigned treatment
Primary	blood glucose	glucose as part of comprehensive metabolic panel with units mg/dL	4 weeks of assigned treatment
Primary	potassium	potassium as part of comprehensive metabolic panel with units mmol/L	baseline
Primary	potassium	potassium as part of comprehensive metabolic panel with units mmol/L	2 weeks of assigned treatment
Primary	potassium	potassium as part of comprehensive metabolic panel with units mmol/L	4 weeks of assigned treatment
Primary	total protein as part of comprehensive metabolic panel with units g/dL	total protein	baseline
Primary	total protein as part of comprehensive metabolic panel with units g/dL	total protein	2 weeks of assigned treatment
Primary	total protein as part of comprehensive metabolic panel with units g/dL	total protein	4 weeks of assigned treatment
Primary	sodium	sodium as part of comprehensive metabolic panel with units mmol/L	baseline
Primary	sodium	sodium as part of comprehensive metabolic panel with units mmol/L	2 weeks of assigned treatment
Primary	sodium	sodium as part of comprehensive metabolic panel with units mmol/L	4 weeks of assigned treatment
Primary	total globulin	total globulin as part of comprehensive metabolic panel with units g/dL	baseline
Primary	total globulin	total globulin as part of comprehensive metabolic panel with units g/dL	2 weeks of assigned treatment
Primary	total globulin	total globulin as part of comprehensive metabolic panel with units g/dL	4 weeks of assigned treatment
Primary	albumin/globulin ratio	albumin/globulin ratio as part of comprehensive metabolic panel	baseline
Primary	albumin/globulin ratio	albumin/globulin ratio as part of comprehensive metabolic panel	2 weeks of assigned treatment
Primary	albumin/globulin ratio	albumin/globulin ratio as part of comprehensive metabolic panel	4 weeks of assigned treatment
Primary	blood urea nitrogen/creatinine ratio	blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel	baseline
Primary	blood urea nitrogen/creatinine ratio	blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel	2 weeks of assigned treatment
Primary	blood urea nitrogen/creatinine ratio	blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel	4 weeks of assigned treatment
Primary	Hematocrit	Hematocrit as part of complete blood count panel with differential test measured as percentage	baseline
Primary	Hematocrit	Hematocrit as part of complete blood count panel with differential test measured as percentage	2 weeks of assigned treatment
Primary	Hematocrit	Hematocrit as part of complete blood count panel with differential test measured as percentage	4 weeks of assigned treatment
Primary	hemoglobin	hemoglobin as part of complete blood count panel with differential test measured as g/dL	baseline
Primary	hemoglobin	hemoglobin as part of complete blood count panel with differential test measured as g/dL	2 weeks of assigned treatment
Primary	hemoglobin	hemoglobin as part of complete blood count panel with differential test measured as g/dL	4 weeks of assigned treatment
Primary	mean corpuscular volume	mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter	baseline
Primary	mean corpuscular volume	mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter	2 weeks of assigned treatment
Primary	mean corpuscular volume	mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter	4 weeks of assigned treatment
Primary	mean corpuscular hemoglobin concentration	mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL	baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Red cell distribution width	red cell distribution width as part of complete blood count panel with differential test measured as percentage	baseline
Primary	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
Primary	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
Primary	platelet count	platelet count per microliter as part of complete blood count panel with differential test	baseline
Primary	platelet count	platelet count per microliter as part of complete blood count panel with differential test	2 weeks of assigned treatment
Primary	platelet count	platelet count per microliter as part of complete blood count panel with differential test	4 weeks of assigned treatment
Primary	red cell count	red cell count per microliter as part of complete blood count panel with differential test	baseline
Primary	red cell count	red cell count per microliter as part of complete blood count panel with differential test	2 weeks of assigned treatment
Primary	red cell count	red cell count per microliter as part of complete blood count panel with differential test	4 weeks of assigned treatment
Primary	white cell count	white cell count per microliter as part of complete blood count panel with differential test	baseline
Primary	white cell count	white cell count per microliter as part of complete blood count panel with differential test	2 weeks of assigned treatment
Primary	white cell count	white cell count per microliter as part of complete blood count panel with differential test	4 weeks of assigned treatment
Primary	Triiodothyronine	Triiodothyronine measured in blood as ng/dL	baseline
Primary	Triiodothyronine	Triiodothyronine measured in blood as ng/dL	2 weeks of assigned treatment
Primary	Triiodothyronine	Triiodothyronine measured in blood as ng/dL	4 weeks of assigned treatment
Primary	Thyroxine	Thyroxine measured in blood as ug/dL	baseline
Primary	Thyroxine	Thyroxine ug/dL measured in blood as ug/dL	2 weeks of assigned treatment
Primary	Thyroxine	Thyroxine ug/dL measured in blood as ug/dL	4 weeks of assigned treatment
Primary	thyroid stimulating hormone	Thyroxine measured in blood as micro-IU/dL	baseline
Primary	thyroid stimulating hormone	Thyroxine measured in blood as micro-IU/dL	2 weeks of assigned treatment
Primary	thyroid stimulating hormone	Thyroxine measured in blood as micro-IU/dL	4 weeks of assigned treatment
Primary	Urine Color	Urine color as reported in complete urinalysis	baseline
Primary	Urine Color	Urine color as reported in complete urinalysis	2 weeks of assigned treatment
Primary	Urine Color	Urine color as reported in complete urinalysis	4 weeks of assigned treatment
Primary	Urine appearance	Urine appearance as reported in complete urinalysis	baseline
Primary	Urine appearance	Urine appearance as reported in complete urinalysis	2 weeks of assigned treatment
Primary	Urine appearance	Urine appearance as reported in complete urinalysis	4 weeks of assigned treatment
Primary	Urine specific gravity	Urine specific gravity as reported in complete urinalysis	baseline
Primary	Urine specific gravity	Urine specific gravity as reported in complete urinalysis	2 weeks of assigned treatment
Primary	Urine specific gravity	Urine specific gravity as reported in complete urinalysis	4 weeks of assigned treatment
Primary	Urine potential of hydrogen	Urine potential of hydrogen (pH) as reported in complete urinalysis	baseline
Primary	Urine potential of hydrogen	Urine potential of hydrogen (pH) as reported in complete urinalysis	2 weeks of assigned treatment
Primary	Urine potential of hydrogen	Urine potential of hydrogen (pH) as reported in complete urinalysis	4 weeks of assigned treatment
Primary	Protein in urine	Protein, if present, measured in urine in complete urinalysis	baseline
Primary	Protein in urine	Protein, if present, measured in urine in complete urinalysis	2 weeks of assigned treatment
Primary	Protein in urine	Protein, if present, measured in urine in complete urinalysis	4 weeks of assigned treatment
Primary	Glucose in urine	Glucose, if present, measured in urine in complete urinalysis	baseline
Primary	Glucose in urine	Glucose, if present, measured in urine in complete urinalysis	2 weeks of assigned treatment
Primary	Glucose in urine	Glucose, if present, measured in urine in complete urinalysis	4 weeks of assigned treatment
Primary	Ketones in urine	Ketones, if present, measured in urine in complete urinalysis	baseline
Primary	Ketones in urine	Ketones, if present, measured in urine in complete urinalysis	2 weeks of assigned treatment
Primary	Ketones in urine	Ketones, if present, measured in urine in complete urinalysis	4 weeks of assigned treatment
Primary	Occult blood in urine	Occult blood, if present, measured in urine in complete urinalysis	baseline
Primary	Occult blood in urine	Occult blood, if present, measured in urine in complete urinalysis	2 weeks of assigned treatment
Primary	Occult blood in urine	Occult blood, if present, measured in urine in complete urinalysis	4 weeks of assigned treatment
Primary	White blood cell esterase in urine	White blood cell esterase, if present, measured in urine	baseline
Primary	White blood cell esterase in urine	White blood cell esterase, if present, measured in urine	2 weeks of assigned treatment
Primary	White blood cell esterase in urine	White blood cell esterase, if present, measured in urine	4 weeks of assigned treatment
Primary	Urine nitrite	nitrite, if present, measured in urine	baseline
Primary	Urine nitrite	nitrite, if present, measured in urine	2 weeks of assigned treatment
Primary	Urine nitrite	nitrite, if present, measured in urine	4 weeks of assigned treatment
Primary	bilirubin in urine	bilirubin, if present, measured in urine	baseline
Primary	bilirubin in urine	bilirubin, if present, measured in urine	2 weeks of assigned treatment
Primary	bilirubin in urine	bilirubin, if present, measured in urine	4 weeks of assigned treatment
Primary	urobilinogen in urine	urobilinogen in urine measured in urinalysis as mg/dL	baseline
Primary	urobilinogen in urine	urobilinogen in urine measured in urinalysis as mg/dL	2 weeks of assigned treatment
Primary	urobilinogen in urine	urobilinogen in urine measured in urinalysis as mg/dL	4 weeks of assigned treatment
Primary	Heart Rate	Heart Rate measured using an automated blood pressure machine	baseline
Primary	Heart Rate	Heart rate measured using an automated blood pressure machine	2 weeks of assigned treatment
Primary	Heart Rate	Heart rate measured using an automated blood pressure machine	4 weeks of assigned treatment
Primary	Blood Pressure	Systolic and Diastolic blood pressure measured using an automated blood pressure machine	baseline
Primary	Blood Pressure	Systolic and Diastolic blood pressure measured using an automated blood pressure machine	2 weeks of assigned treatment
Primary	Blood Pressure	Systolic and Diastolic blood pressure measured using an automated blood pressure machine	4 weeks of assigned treatment
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Daily food diary	A list of all food and drink consumed that day	3 days before baseline visit
Primary	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
Primary	Daily food diary	A list of all food and drink consumed that day	2 days before baseline visit
Primary	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
Primary	Daily food diary	A list of all food and drink consumed that day	1 day before baseline visit
Primary	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
Primary	Daily food diary	A list of all food and drink consumed that day	3 days before 2 week visit
Primary	Daily food diary	A list of all food and drink consumed that day	2 days before 2 week visit
Primary	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
Primary	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
Primary	Daily food diary	A list of all food and drink consumed that day	1 day before 2 week visit
Primary	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
Primary	Daily food diary	A list of all food and drink consumed that day	3 days before 4 week visit
Primary	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
Primary	Daily food diary	A list of all food and drink consumed that day	2 days before 4 week visit
Primary	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
Primary	Daily food diary	A list of all food and drink consumed that day	1 day before 4 week visit