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OpenTrials
Completed

NCT Number: NCT05592951

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.

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Key information

Conditions

Safety Tolerance

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crystal Light (once serving)

Dietary Supplement

Citric Acid, Potassium Citrate, Sodium Citrate, Aspartame (Phenylketonurics: Contains Phenylalanine), Magnesium Oxide, Maltodextrin, Contains Less than 2% of Natural Flavor, Acesulfame Potassium, Soy Lecithin, Yellow 5, Artificial Color.

Liquid IV with amino acids (one serving)

Dietary Supplement

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)

Dietary Supplement

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)

Dietary Supplement

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.

Primary outcomes

  1. Alanine transaminase

    Time frame: baseline

    Alanine transaminase measured as part of metabolic panel with units IU/L

  2. Alanine transaminase

    Time frame: 2 weeks of assigned treatment

    Alanine transaminase measured as part of metabolic panel with units IU/L

  3. Alanine transaminase

    Time frame: 4 weeks of assigned treatment

    Alanine transaminase measured as part of metabolic panel with units IU/L

  4. Aspartate transferase

    Time frame: baseline

    Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L

  5. Aspartate transferase

    Time frame: 2 weeks of assigned treatment

    Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L

  6. Aspartate transferase

    Time frame: 4 weeks of assigned treatment

    Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L

  7. Albumin

    Time frame: baseline

    Albumin measured as part of comprehensive metabolic panel with units g/dL

  8. Albumin

    Time frame: 2 weeks of assigned treatment

    Albumin measured as part of comprehensive metabolic panel with units g/dL

  9. Albumin

    Time frame: 4 weeks of assigned treatment

    Albumin measured as part of comprehensive metabolic panel with units g/dL

  10. Alkaline phosphatase

    Time frame: baseline

    Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L

  11. Alkaline phosphatase

    Time frame: 2 weeks of assigned treatment

    Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L

  12. Alkaline phosphatase

    Time frame: 4 weeks of assigned treatment

    Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L

  13. total bilirubin

    Time frame: baseline

    total bilirubin measured as part of comprehensive metabolic panel with units mg/dL

  14. total bilirubin

    Time frame: 2 weeks of assigned treatment

    total bilirubin measured as part of comprehensive metabolic panel with units mg/dL

  15. total bilirubin

    Time frame: 4 weeks of assigned treatment

    total bilirubin measured as part of comprehensive metabolic panel with units mg/dL

  16. blood urea nitrogen mg/dL

    Time frame: baseline

    blood urea nitrogen as part of comprehensive metabolic panel with unite

  17. blood urea nitrogen

    Time frame: 2 weeks of assigned treatment

    blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL

  18. blood urea nitrogen

    Time frame: 4 weeks of assigned treatment

    blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL

  19. calcium

    Time frame: baseline

    calcium as part of comprehensive metabolic panel with units mg/dL

  20. calcium

    Time frame: 2 weeks of assigned treatment

    calcium as part of comprehensive metabolic panel with units mg/dL

  21. calcium

    Time frame: 4 weeks of assigned treatment

    calcium as part of comprehensive metabolic panel with units mg/dL

  22. carbon dioxide

    Time frame: baseline

    carbon dioxide as part of comprehensive metabolic panel with units mmol/L

  23. carbon dioxide

    Time frame: 2 weeks of assigned treatment

    carbon dioxide as part of comprehensive metabolic panel with units mmol/L

  24. carbon dioxide

    Time frame: 4 weeks of assigned treatment

    carbon dioxide as part of comprehensive metabolic panel with units mmol/L

  25. chloride

    Time frame: baseline

    chloride as part of comprehensive metabolic panel with units mmol/L

  26. chloride

    Time frame: 2 weeks of assigned treatment

    chloride as part of comprehensive metabolic panel with units mmol/L

  27. chloride

    Time frame: 4 weeks of assigned treatment

    chloride as part of comprehensive metabolic panel with units mmol/L

  28. creatinine

    Time frame: baseline

    creatinine as part of comprehensive metabolic panel with units mg/dL

  29. creatinine

    Time frame: 2 weeks of assigned treatment

    creatinine as part of comprehensive metabolic panel with units mg/dL

  30. creatinine

    Time frame: 4 weeks of assigned treatment

    creatinine as part of comprehensive metabolic panel with units mg/dL

  31. estimated glomerular filtration rate calculation

    Time frame: baseline

    estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73

  32. estimated glomerular filtration rate calculation

    Time frame: 2 weeks of assigned treatment

    estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73

  33. estimated glomerular filtration rate calculation

    Time frame: 4 weeks of assigned treatment

    estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73

  34. blood glucose

    Time frame: baseline

    glucose as part of comprehensive metabolic panel with units mg/dL

  35. blood glucose

    Time frame: 2 weeks of assigned treatment

    glucose as part of comprehensive metabolic panel with units mg/dL

  36. blood glucose

    Time frame: 4 weeks of assigned treatment

    glucose as part of comprehensive metabolic panel with units mg/dL

  37. potassium

    Time frame: baseline

    potassium as part of comprehensive metabolic panel with units mmol/L

  38. potassium

    Time frame: 2 weeks of assigned treatment

    potassium as part of comprehensive metabolic panel with units mmol/L

  39. potassium

    Time frame: 4 weeks of assigned treatment

    potassium as part of comprehensive metabolic panel with units mmol/L

  40. total protein as part of comprehensive metabolic panel with units g/dL

    Time frame: baseline

    total protein

  41. total protein as part of comprehensive metabolic panel with units g/dL

    Time frame: 2 weeks of assigned treatment

    total protein

  42. total protein as part of comprehensive metabolic panel with units g/dL

    Time frame: 4 weeks of assigned treatment

    total protein

  43. sodium

    Time frame: baseline

    sodium as part of comprehensive metabolic panel with units mmol/L

  44. sodium

    Time frame: 2 weeks of assigned treatment

    sodium as part of comprehensive metabolic panel with units mmol/L

  45. sodium

    Time frame: 4 weeks of assigned treatment

    sodium as part of comprehensive metabolic panel with units mmol/L

  46. total globulin

    Time frame: baseline

    total globulin as part of comprehensive metabolic panel with units g/dL

  47. total globulin

    Time frame: 2 weeks of assigned treatment

    total globulin as part of comprehensive metabolic panel with units g/dL

  48. total globulin

    Time frame: 4 weeks of assigned treatment

    total globulin as part of comprehensive metabolic panel with units g/dL

  49. albumin/globulin ratio

    Time frame: baseline

    albumin/globulin ratio as part of comprehensive metabolic panel

  50. albumin/globulin ratio

    Time frame: 2 weeks of assigned treatment

    albumin/globulin ratio as part of comprehensive metabolic panel

  51. albumin/globulin ratio

    Time frame: 4 weeks of assigned treatment

    albumin/globulin ratio as part of comprehensive metabolic panel

  52. blood urea nitrogen/creatinine ratio

    Time frame: baseline

    blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel

  53. blood urea nitrogen/creatinine ratio

    Time frame: 2 weeks of assigned treatment

    blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel

  54. blood urea nitrogen/creatinine ratio

    Time frame: 4 weeks of assigned treatment

    blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel

  55. Hematocrit

    Time frame: baseline

    Hematocrit as part of complete blood count panel with differential test measured as percentage

  56. Hematocrit

    Time frame: 2 weeks of assigned treatment

    Hematocrit as part of complete blood count panel with differential test measured as percentage

  57. Hematocrit

    Time frame: 4 weeks of assigned treatment

    Hematocrit as part of complete blood count panel with differential test measured as percentage

  58. hemoglobin

    Time frame: baseline

    hemoglobin as part of complete blood count panel with differential test measured as g/dL

  59. hemoglobin

    Time frame: 2 weeks of assigned treatment

    hemoglobin as part of complete blood count panel with differential test measured as g/dL

  60. hemoglobin

    Time frame: 4 weeks of assigned treatment

    hemoglobin as part of complete blood count panel with differential test measured as g/dL

  61. mean corpuscular volume

    Time frame: baseline

    mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter

  62. mean corpuscular volume

    Time frame: 2 weeks of assigned treatment

    mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter

  63. mean corpuscular volume

    Time frame: 4 weeks of assigned treatment

    mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter

  64. mean corpuscular hemoglobin concentration

    Time frame: baseline

    mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL

  65. mean corpuscular hemoglobin concentration

    Time frame: 2 weeks of assigned treatment

    mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL

  66. mean corpuscular hemoglobin concentration

    Time frame: 4 weeks of assigned treatment

    mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL

  67. White blood cell distribution (absolute)

    Time frame: baseline

    absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel

  68. White blood cell distribution (absolute)

    Time frame: 2 weeks of assigned treatment

    absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel

  69. White blood cell distribution (absolute)

    Time frame: 4 weeks of assigned treatment

    absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel

  70. White blood cell distribution (percentage)

    Time frame: baseline

    percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.

  71. White blood cell distribution (percentage)

    Time frame: 2 weeks of assigned treatment

    percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.

  72. White blood cell distribution (percentage)

    Time frame: 4 weeks of assigned treatment

    percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.

  73. Red cell distribution width

    Time frame: baseline

    red cell distribution width as part of complete blood count panel with differential test measured as percentage

  74. Red cell distribution width

    Time frame: 2 weeks of assigned treatment

    red cell distribution width as part of complete blood count panel with differential test measured as percentage

  75. Red cell distribution width

    Time frame: 4 weeks of assigned treatment

    red cell distribution width as part of complete blood count panel with differential test measured as percentage

  76. platelet count

    Time frame: baseline

    platelet count per microliter as part of complete blood count panel with differential test

  77. platelet count

    Time frame: 2 weeks of assigned treatment

    platelet count per microliter as part of complete blood count panel with differential test

  78. platelet count

    Time frame: 4 weeks of assigned treatment

    platelet count per microliter as part of complete blood count panel with differential test

  79. red cell count

    Time frame: baseline

    red cell count per microliter as part of complete blood count panel with differential test

  80. red cell count

    Time frame: 2 weeks of assigned treatment

    red cell count per microliter as part of complete blood count panel with differential test

  81. red cell count

    Time frame: 4 weeks of assigned treatment

    red cell count per microliter as part of complete blood count panel with differential test

  82. white cell count

    Time frame: baseline

    white cell count per microliter as part of complete blood count panel with differential test

  83. white cell count

    Time frame: 2 weeks of assigned treatment

    white cell count per microliter as part of complete blood count panel with differential test

  84. white cell count

    Time frame: 4 weeks of assigned treatment

    white cell count per microliter as part of complete blood count panel with differential test

  85. Triiodothyronine

    Time frame: baseline

    Triiodothyronine measured in blood as ng/dL

  86. Triiodothyronine

    Time frame: 2 weeks of assigned treatment

    Triiodothyronine measured in blood as ng/dL

  87. Triiodothyronine

    Time frame: 4 weeks of assigned treatment

    Triiodothyronine measured in blood as ng/dL

  88. Thyroxine

    Time frame: baseline

    Thyroxine measured in blood as ug/dL

  89. Thyroxine

    Time frame: 2 weeks of assigned treatment

    Thyroxine ug/dL measured in blood as ug/dL

  90. Thyroxine

    Time frame: 4 weeks of assigned treatment

    Thyroxine ug/dL measured in blood as ug/dL

  91. thyroid stimulating hormone

    Time frame: baseline

    Thyroxine measured in blood as micro-IU/dL

  92. thyroid stimulating hormone

    Time frame: 2 weeks of assigned treatment

    Thyroxine measured in blood as micro-IU/dL

  93. thyroid stimulating hormone

    Time frame: 4 weeks of assigned treatment

    Thyroxine measured in blood as micro-IU/dL

  94. Urine Color

    Time frame: baseline

    Urine color as reported in complete urinalysis

  95. Urine Color

    Time frame: 2 weeks of assigned treatment

    Urine color as reported in complete urinalysis

  96. Urine Color

    Time frame: 4 weeks of assigned treatment

    Urine color as reported in complete urinalysis

  97. Urine appearance

    Time frame: baseline

    Urine appearance as reported in complete urinalysis

  98. Urine appearance

    Time frame: 2 weeks of assigned treatment

    Urine appearance as reported in complete urinalysis

  99. Urine appearance

    Time frame: 4 weeks of assigned treatment

    Urine appearance as reported in complete urinalysis

  100. Urine specific gravity

    Time frame: baseline

    Urine specific gravity as reported in complete urinalysis

  101. Urine specific gravity

    Time frame: 2 weeks of assigned treatment

    Urine specific gravity as reported in complete urinalysis

  102. Urine specific gravity

    Time frame: 4 weeks of assigned treatment

    Urine specific gravity as reported in complete urinalysis

  103. Urine potential of hydrogen

    Time frame: baseline

    Urine potential of hydrogen (pH) as reported in complete urinalysis

  104. Urine potential of hydrogen

    Time frame: 2 weeks of assigned treatment

    Urine potential of hydrogen (pH) as reported in complete urinalysis

  105. Urine potential of hydrogen

    Time frame: 4 weeks of assigned treatment

    Urine potential of hydrogen (pH) as reported in complete urinalysis

  106. Protein in urine

    Time frame: baseline

    Protein, if present, measured in urine in complete urinalysis

  107. Protein in urine

    Time frame: 2 weeks of assigned treatment

    Protein, if present, measured in urine in complete urinalysis

  108. Protein in urine

    Time frame: 4 weeks of assigned treatment

    Protein, if present, measured in urine in complete urinalysis

  109. Glucose in urine

    Time frame: baseline

    Glucose, if present, measured in urine in complete urinalysis

  110. Glucose in urine

    Time frame: 2 weeks of assigned treatment

    Glucose, if present, measured in urine in complete urinalysis

  111. Glucose in urine

    Time frame: 4 weeks of assigned treatment

    Glucose, if present, measured in urine in complete urinalysis

  112. Ketones in urine

    Time frame: baseline

    Ketones, if present, measured in urine in complete urinalysis

  113. Ketones in urine

    Time frame: 2 weeks of assigned treatment

    Ketones, if present, measured in urine in complete urinalysis

  114. Ketones in urine

    Time frame: 4 weeks of assigned treatment

    Ketones, if present, measured in urine in complete urinalysis

  115. Occult blood in urine

    Time frame: baseline

    Occult blood, if present, measured in urine in complete urinalysis

  116. Occult blood in urine

    Time frame: 2 weeks of assigned treatment

    Occult blood, if present, measured in urine in complete urinalysis

  117. Occult blood in urine

    Time frame: 4 weeks of assigned treatment

    Occult blood, if present, measured in urine in complete urinalysis

  118. White blood cell esterase in urine

    Time frame: baseline

    White blood cell esterase, if present, measured in urine

  119. White blood cell esterase in urine

    Time frame: 2 weeks of assigned treatment

    White blood cell esterase, if present, measured in urine

  120. White blood cell esterase in urine

    Time frame: 4 weeks of assigned treatment

    White blood cell esterase, if present, measured in urine

  121. Urine nitrite

    Time frame: baseline

    nitrite, if present, measured in urine

  122. Urine nitrite

    Time frame: 2 weeks of assigned treatment

    nitrite, if present, measured in urine

  123. Urine nitrite

    Time frame: 4 weeks of assigned treatment

    nitrite, if present, measured in urine

  124. bilirubin in urine

    Time frame: baseline

    bilirubin, if present, measured in urine

  125. bilirubin in urine

    Time frame: 2 weeks of assigned treatment

    bilirubin, if present, measured in urine

  126. bilirubin in urine

    Time frame: 4 weeks of assigned treatment

    bilirubin, if present, measured in urine

  127. urobilinogen in urine

    Time frame: baseline

    urobilinogen in urine measured in urinalysis as mg/dL

  128. urobilinogen in urine

    Time frame: 2 weeks of assigned treatment

    urobilinogen in urine measured in urinalysis as mg/dL

  129. urobilinogen in urine

    Time frame: 4 weeks of assigned treatment

    urobilinogen in urine measured in urinalysis as mg/dL

  130. Heart Rate

    Time frame: baseline

    Heart Rate measured using an automated blood pressure machine

  131. Heart Rate

    Time frame: 2 weeks of assigned treatment

    Heart rate measured using an automated blood pressure machine

  132. Heart Rate

    Time frame: 4 weeks of assigned treatment

    Heart rate measured using an automated blood pressure machine

  133. Blood Pressure

    Time frame: baseline

    Systolic and Diastolic blood pressure measured using an automated blood pressure machine

  134. Blood Pressure

    Time frame: 2 weeks of assigned treatment

    Systolic and Diastolic blood pressure measured using an automated blood pressure machine

  135. Blood Pressure

    Time frame: 4 weeks of assigned treatment

    Systolic and Diastolic blood pressure measured using an automated blood pressure machine

  136. Product Tolerability questionnaire (gastrointestinal)

    Time frame: baseline

    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)

  137. Product Tolerability questionnaire (gastrointestinal)

    Time frame: 2 weeks of assigned treatment

    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)

  138. Product Tolerability questionnaire (gastrointestinal)

    Time frame: 4 weeks of assigned treatment

    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)

  139. Product Tolerability questionnaire (consumption)

    Time frame: baseline

    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.

  140. Product Tolerability questionnaire (consumption)

    Time frame: 2 weeks of assigned treatment

    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.

  141. Product Tolerability questionnaire (consumption)

    Time frame: 4 weeks of assigned treatment visit

    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.

  142. tolerability questionnaire

    Time frame: 3 days before baseline visit

    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)

  143. Daily food diary

    Time frame: 3 days before baseline visit

    A list of all food and drink consumed that day

  144. tolerability questionnaire

    Time frame: 2 days before baseline visit

    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)

  145. Daily food diary

    Time frame: 2 days before baseline visit

    A list of all food and drink consumed that day

  146. tolerability questionnaire

    Time frame: 1 day before baseline visit

    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)

  147. Daily food diary

    Time frame: 1 day before baseline visit

    A list of all food and drink consumed that day

  148. tolerability questionnaire

    Time frame: 3 days before 2 week visit

    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)

  149. Daily food diary

    Time frame: 3 days before 2 week visit

    A list of all food and drink consumed that day

  150. Daily food diary

    Time frame: 2 days before 2 week visit

    A list of all food and drink consumed that day

  151. tolerability questionnaire

    Time frame: 2 days before 2 week visit

    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)

  152. tolerability questionnaire

    Time frame: 1 day before 2 week visit

    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)

  153. Daily food diary

    Time frame: 1 day before 2 week visit

    A list of all food and drink consumed that day

  154. tolerability questionnaire

    Time frame: 3 days before 4 week visit

    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)

  155. Daily food diary

    Time frame: 3 days before 4 week visit

    A list of all food and drink consumed that day

  156. tolerability questionnaire

    Time frame: 2 days before 4 week visit

    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)

  157. Daily food diary

    Time frame: 2 days before 4 week visit

    A list of all food and drink consumed that day

  158. tolerability questionnaire

    Time frame: 1 day before 4 week visit

    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)

  159. Daily food diary

    Time frame: 1 day before 4 week visit

    A list of all food and drink consumed that day

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Collaborators

  • Unilever R&D

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2022
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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