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.
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
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
40
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.
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, United States
Alanine transaminase
Alanine transaminase measured as part of metabolic panel with units IU/L
Time frame: baseline
Alanine transaminase
Alanine transaminase measured as part of metabolic panel with units IU/L
Time frame: 2 weeks of assigned treatment
Alanine transaminase
Alanine transaminase measured as part of metabolic panel with units IU/L
Time frame: 4 weeks of assigned treatment
Aspartate transferase
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
Time frame: baseline
Aspartate transferase
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
Time frame: 2 weeks of assigned treatment
Aspartate transferase
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
Time frame: 4 weeks of assigned treatment
Albumin
Albumin measured as part of comprehensive metabolic panel with units g/dL
Time frame: baseline
Albumin
Albumin measured as part of comprehensive metabolic panel with units g/dL
Time frame: 2 weeks of assigned treatment
Albumin
Albumin measured as part of comprehensive metabolic panel with units g/dL
Time frame: 4 weeks of assigned treatment
Alkaline phosphatase
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
Time frame: baseline
Alkaline phosphatase
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
Time frame: 2 weeks of assigned treatment
Alkaline phosphatase
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
Time frame: 4 weeks of assigned treatment
total bilirubin
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
Time frame: baseline
total bilirubin
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
Time frame: 2 weeks of assigned treatment
total bilirubin
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
Time frame: 4 weeks of assigned treatment
blood urea nitrogen mg/dL
blood urea nitrogen as part of comprehensive metabolic panel with unite
Time frame: baseline
blood urea nitrogen
blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL
Time frame: 2 weeks of assigned treatment
blood urea nitrogen
blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL
Time frame: 4 weeks of assigned treatment
calcium
calcium as part of comprehensive metabolic panel with units mg/dL
Time frame: baseline
calcium
calcium as part of comprehensive metabolic panel with units mg/dL
Time frame: 2 weeks of assigned treatment
calcium
calcium as part of comprehensive metabolic panel with units mg/dL
Time frame: 4 weeks of assigned treatment
carbon dioxide
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
Time frame: baseline
carbon dioxide
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
Time frame: 2 weeks of assigned treatment
carbon dioxide
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
Time frame: 4 weeks of assigned treatment
chloride
chloride as part of comprehensive metabolic panel with units mmol/L
Time frame: baseline
chloride
chloride as part of comprehensive metabolic panel with units mmol/L
Time frame: 2 weeks of assigned treatment
chloride
chloride as part of comprehensive metabolic panel with units mmol/L
Time frame: 4 weeks of assigned treatment
creatinine
creatinine as part of comprehensive metabolic panel with units mg/dL
Time frame: baseline
creatinine
creatinine as part of comprehensive metabolic panel with units mg/dL
Time frame: 2 weeks of assigned treatment
creatinine
creatinine as part of comprehensive metabolic panel with units mg/dL
Time frame: 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
Time frame: baseline
estimated glomerular filtration rate calculation
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
Time frame: 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
Time frame: 4 weeks of assigned treatment
blood glucose
glucose as part of comprehensive metabolic panel with units mg/dL
Time frame: baseline
blood glucose
glucose as part of comprehensive metabolic panel with units mg/dL
Time frame: 2 weeks of assigned treatment
blood glucose
glucose as part of comprehensive metabolic panel with units mg/dL
Time frame: 4 weeks of assigned treatment
potassium
potassium as part of comprehensive metabolic panel with units mmol/L
Time frame: baseline
potassium
potassium as part of comprehensive metabolic panel with units mmol/L
Time frame: 2 weeks of assigned treatment
potassium
potassium as part of comprehensive metabolic panel with units mmol/L
Time frame: 4 weeks of assigned treatment
total protein as part of comprehensive metabolic panel with units g/dL
total protein
Time frame: baseline
total protein as part of comprehensive metabolic panel with units g/dL
total protein
Time frame: 2 weeks of assigned treatment
total protein as part of comprehensive metabolic panel with units g/dL
total protein
Time frame: 4 weeks of assigned treatment
sodium
sodium as part of comprehensive metabolic panel with units mmol/L
Time frame: baseline
sodium
sodium as part of comprehensive metabolic panel with units mmol/L
Time frame: 2 weeks of assigned treatment
sodium
sodium as part of comprehensive metabolic panel with units mmol/L
Time frame: 4 weeks of assigned treatment
total globulin
total globulin as part of comprehensive metabolic panel with units g/dL
Time frame: baseline
total globulin
total globulin as part of comprehensive metabolic panel with units g/dL
Time frame: 2 weeks of assigned treatment
total globulin
total globulin as part of comprehensive metabolic panel with units g/dL
Time frame: 4 weeks of assigned treatment
albumin/globulin ratio
albumin/globulin ratio as part of comprehensive metabolic panel
Time frame: baseline
albumin/globulin ratio
albumin/globulin ratio as part of comprehensive metabolic panel
Time frame: 2 weeks of assigned treatment
albumin/globulin ratio
albumin/globulin ratio as part of comprehensive metabolic panel
Time frame: 4 weeks of assigned treatment
blood urea nitrogen/creatinine ratio
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
Time frame: baseline
blood urea nitrogen/creatinine ratio
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
Time frame: 2 weeks of assigned treatment
blood urea nitrogen/creatinine ratio
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
Time frame: 4 weeks of assigned treatment
Hematocrit
Hematocrit as part of complete blood count panel with differential test measured as percentage
Time frame: baseline
Hematocrit
Hematocrit as part of complete blood count panel with differential test measured as percentage
Time frame: 2 weeks of assigned treatment
Hematocrit
Hematocrit as part of complete blood count panel with differential test measured as percentage
Time frame: 4 weeks of assigned treatment
hemoglobin
hemoglobin as part of complete blood count panel with differential test measured as g/dL
Time frame: baseline
hemoglobin
hemoglobin as part of complete blood count panel with differential test measured as g/dL
Time frame: 2 weeks of assigned treatment
hemoglobin
hemoglobin as part of complete blood count panel with differential test measured as g/dL
Time frame: 4 weeks of assigned treatment
mean corpuscular volume
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
Time frame: baseline
mean corpuscular volume
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
Time frame: 2 weeks of assigned treatment
mean corpuscular volume
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
Time frame: 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
Time frame: baseline
mean corpuscular hemoglobin concentration
mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: baseline
Red cell distribution width
red cell distribution width as part of complete blood count panel with differential test measured as percentage
Time frame: 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
Time frame: 4 weeks of assigned treatment
platelet count
platelet count per microliter as part of complete blood count panel with differential test
Time frame: baseline
platelet count
platelet count per microliter as part of complete blood count panel with differential test
Time frame: 2 weeks of assigned treatment
platelet count
platelet count per microliter as part of complete blood count panel with differential test
Time frame: 4 weeks of assigned treatment
red cell count
red cell count per microliter as part of complete blood count panel with differential test
Time frame: baseline
red cell count
red cell count per microliter as part of complete blood count panel with differential test
Time frame: 2 weeks of assigned treatment
red cell count
red cell count per microliter as part of complete blood count panel with differential test
Time frame: 4 weeks of assigned treatment
white cell count
white cell count per microliter as part of complete blood count panel with differential test
Time frame: baseline
white cell count
white cell count per microliter as part of complete blood count panel with differential test
Time frame: 2 weeks of assigned treatment
white cell count
white cell count per microliter as part of complete blood count panel with differential test
Time frame: 4 weeks of assigned treatment
Triiodothyronine
Triiodothyronine measured in blood as ng/dL
Time frame: baseline
Triiodothyronine
Triiodothyronine measured in blood as ng/dL
Time frame: 2 weeks of assigned treatment
Triiodothyronine
Triiodothyronine measured in blood as ng/dL
Time frame: 4 weeks of assigned treatment
Thyroxine
Thyroxine measured in blood as ug/dL
Time frame: baseline
Thyroxine
Thyroxine ug/dL measured in blood as ug/dL
Time frame: 2 weeks of assigned treatment
Thyroxine
Thyroxine ug/dL measured in blood as ug/dL
Time frame: 4 weeks of assigned treatment
thyroid stimulating hormone
Thyroxine measured in blood as micro-IU/dL
Time frame: baseline
thyroid stimulating hormone
Thyroxine measured in blood as micro-IU/dL
Time frame: 2 weeks of assigned treatment
thyroid stimulating hormone
Thyroxine measured in blood as micro-IU/dL
Time frame: 4 weeks of assigned treatment
Urine Color
Urine color as reported in complete urinalysis
Time frame: baseline
Urine Color
Urine color as reported in complete urinalysis
Time frame: 2 weeks of assigned treatment
Urine Color
Urine color as reported in complete urinalysis
Time frame: 4 weeks of assigned treatment
Urine appearance
Urine appearance as reported in complete urinalysis
Time frame: baseline
Urine appearance
Urine appearance as reported in complete urinalysis
Time frame: 2 weeks of assigned treatment
Urine appearance
Urine appearance as reported in complete urinalysis
Time frame: 4 weeks of assigned treatment
Urine specific gravity
Urine specific gravity as reported in complete urinalysis
Time frame: baseline
Urine specific gravity
Urine specific gravity as reported in complete urinalysis
Time frame: 2 weeks of assigned treatment
Urine specific gravity
Urine specific gravity as reported in complete urinalysis
Time frame: 4 weeks of assigned treatment
Urine potential of hydrogen
Urine potential of hydrogen (pH) as reported in complete urinalysis
Time frame: baseline
Urine potential of hydrogen
Urine potential of hydrogen (pH) as reported in complete urinalysis
Time frame: 2 weeks of assigned treatment
Urine potential of hydrogen
Urine potential of hydrogen (pH) as reported in complete urinalysis
Time frame: 4 weeks of assigned treatment
Protein in urine
Protein, if present, measured in urine in complete urinalysis
Time frame: baseline
Protein in urine
Protein, if present, measured in urine in complete urinalysis
Time frame: 2 weeks of assigned treatment
Protein in urine
Protein, if present, measured in urine in complete urinalysis
Time frame: 4 weeks of assigned treatment
Glucose in urine
Glucose, if present, measured in urine in complete urinalysis
Time frame: baseline
Glucose in urine
Glucose, if present, measured in urine in complete urinalysis
Time frame: 2 weeks of assigned treatment
Glucose in urine
Glucose, if present, measured in urine in complete urinalysis
Time frame: 4 weeks of assigned treatment
Ketones in urine
Ketones, if present, measured in urine in complete urinalysis
Time frame: baseline
Ketones in urine
Ketones, if present, measured in urine in complete urinalysis
Time frame: 2 weeks of assigned treatment
Ketones in urine
Ketones, if present, measured in urine in complete urinalysis
Time frame: 4 weeks of assigned treatment
Occult blood in urine
Occult blood, if present, measured in urine in complete urinalysis
Time frame: baseline
Occult blood in urine
Occult blood, if present, measured in urine in complete urinalysis
Time frame: 2 weeks of assigned treatment
Occult blood in urine
Occult blood, if present, measured in urine in complete urinalysis
Time frame: 4 weeks of assigned treatment
White blood cell esterase in urine
White blood cell esterase, if present, measured in urine
Time frame: baseline
White blood cell esterase in urine
White blood cell esterase, if present, measured in urine
Time frame: 2 weeks of assigned treatment
White blood cell esterase in urine
White blood cell esterase, if present, measured in urine
Time frame: 4 weeks of assigned treatment
Urine nitrite
nitrite, if present, measured in urine
Time frame: baseline
Urine nitrite
nitrite, if present, measured in urine
Time frame: 2 weeks of assigned treatment
Urine nitrite
nitrite, if present, measured in urine
Time frame: 4 weeks of assigned treatment
bilirubin in urine
bilirubin, if present, measured in urine
Time frame: baseline
bilirubin in urine
bilirubin, if present, measured in urine
Time frame: 2 weeks of assigned treatment
bilirubin in urine
bilirubin, if present, measured in urine
Time frame: 4 weeks of assigned treatment
urobilinogen in urine
urobilinogen in urine measured in urinalysis as mg/dL
Time frame: baseline
urobilinogen in urine
urobilinogen in urine measured in urinalysis as mg/dL
Time frame: 2 weeks of assigned treatment
urobilinogen in urine
urobilinogen in urine measured in urinalysis as mg/dL
Time frame: 4 weeks of assigned treatment
Heart Rate
Heart Rate measured using an automated blood pressure machine
Time frame: baseline
Heart Rate
Heart rate measured using an automated blood pressure machine
Time frame: 2 weeks of assigned treatment
Heart Rate
Heart rate measured using an automated blood pressure machine
Time frame: 4 weeks of assigned treatment
Blood Pressure
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
Time frame: baseline
Blood Pressure
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
Time frame: 2 weeks of assigned treatment
Blood Pressure
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 3 days before baseline visit
Daily food diary
A list of all food and drink consumed that day
Time frame: 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)
Time frame: 2 days before baseline visit
Daily food diary
A list of all food and drink consumed that day
Time frame: 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)
Time frame: 1 day before baseline visit
Daily food diary
A list of all food and drink consumed that day
Time frame: 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)
Time frame: 3 days before 2 week visit
Daily food diary
A list of all food and drink consumed that day
Time frame: 3 days before 2 week visit
Daily food diary
A list of all food and drink consumed that day
Time frame: 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)
Time frame: 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)
Time frame: 1 day before 2 week visit
Daily food diary
A list of all food and drink consumed that day
Time frame: 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)
Time frame: 3 days before 4 week visit
Daily food diary
A list of all food and drink consumed that day
Time frame: 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)
Time frame: 2 days before 4 week visit
Daily food diary
A list of all food and drink consumed that day
Time frame: 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)
Time frame: 1 day before 4 week visit
Daily food diary
A list of all food and drink consumed that day
Time frame: 1 day before 4 week visit
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