Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Maintaining adequate hydration is essential to optimal health, as well as athletic performance. When individuals exercise (in particular in a warm environment), they can lose excessive amounts of fluids along with necessary electrolytes (e.g., sodium, potassium, chloride) through sweating. With dehydration, individuals may feel sluggish and can experience impaired physical performance.
The use of electrolytes (sodium in particular) has been used for decades to aid athlete hydration and has led to the development of various sport drinks (e.g., Gatorade, Powerade) -which also include small amounts of carbohydrate. The addition of amino acids to electrolyte solutions has previously been demonstrated to further increase the transport of water and sodium from the jejunum (small intestine). Separate research also showed an amino acid and electrolyte drink increased cellular hydration compared to flavored water and electrolyte only drinks. A 2019 study found that amino acids hydration increased beverage hydration index (BHI)-a measure of fluid balance following consumption of a beverage and was age dependent.
Amino acids supplementation has been popular for some time among athletes due to other potential performance benefits including changes to anabolic hormone levels, alterations to energy consumption, and mental endurance. Further, amino acids may reduce post-exercise muscle soreness and aid in recovery.
The electrolyte amino-acid test product is a powder provided in individual stick packs and contains L-Alanine and L-Glutamine as well as 5 essential vitamins including Vitamins B3, B5, B6, B12 and Vitamin C. It is gluten-, soy-, and dairy-free, and provides electrolytes well below the daily value. The daily value (DV) tells us how much a particular nutrient in a serving of a food product contributes to a daily diet, based on a standard 2000 calorie diet. Despite what the name suggests, this product is taken orally, not intravenously. Liquid IV packets contain: sodium (510 mg, 22%DV) and potassium (380 mg, 8%DV). These packets contain a small percentage of the needed total electrolytes but adequate amounts to replace lost electrolytes as a result of physical activity.
The nutrient composition of this product is similar to the existing Liquid IV "hydration multiplier" product already on the market but with the addition of amino acids. With such low quantities of amino acids, in particular as compared to the amounts consumed in normal diets, there is no reason to believe that the product would cause any adverse outcomes. However, since no research has been done on the safety of regular consumption of this product, this study will evaluate the safety of the product with regards to routing blood chemistries and other variables. Specifically, standard testing will be performed including a measurement of vital signs, comprehensive metabolic panel, hematology panel, urinalysis, and quantification of triiodothyronine, thyroxine, and thyroid stimulating hormone. A questionnaire will also be used to assess product tolerability.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo once daily 1 stick pack dissolved in water once daily prior to breakfast |
Dietary Supplement: Crystal Light (once serving)
Citric Acid, Potassium Citrate, Sodium Citrate, Aspartame (Phenylketonurics: Contains Phenylalanine), Magnesium Oxide, Maltodextrin, Contains Less than 2% of Natural Flavor, Acesulfame Potassium, Soy Lecithin, Yellow 5, Artificial Color.
|
| Experimental: Test beverage once daily 1 stick pack dissolved in water once daily prior to breakfast |
Dietary Supplement: Liquid IV with amino acids (one serving)
Allulose, L-Alanine, L-Glutamine, Citric Acid, Sodium chloride, Lemon Lime Flavorings, Potassium Citrate, Trisodium Citrate Dihydrate, Dipotassium Phosphate, Syloid Silicon Dioxide, Stevia, Vitamin C, Vitamin B3, Calcium Pantothenate B5 (Vitamin B5), Vitamin B6, Vitamin B12. Liquid IV packets contain: sodium and potassium.
|
| Experimental: Test beverage twice daily 2 stick packs dissolved in water, one packet at a time twice daily (after lunch and after dinner) |
Dietary Supplement: Liquid IV with amino acids (two servings)
Allulose, L-Alanine, L-Glutamine, Citric Acid, Sodium chloride, Lemon Lime Flavorings, Potassium Citrate, Trisodium Citrate Dihydrate, Dipotassium Phosphate, Syloid Silicon Dioxide, Stevia, Vitamin C, Vitamin B3, Calcium Pantothenate B5 (Vitamin B5), Vitamin B6, Vitamin B12. Liquid IV packets contain: sodium and potassium.
|
| Experimental: Test beverage three times daily 3 stick packs dissolved in water, one packet at a time three times daily (after breakfast, lunch, and dinner) |
Dietary Supplement: Liquid IV with amino acids (three servings)
Allulose, L-Alanine, L-Glutamine, Citric Acid, Sodium chloride, Lemon Lime Flavorings, Potassium Citrate, Trisodium Citrate Dihydrate, Dipotassium Phosphate, Syloid Silicon Dioxide, Stevia, Vitamin C, Vitamin B3, Calcium Pantothenate B5 (Vitamin B5), Vitamin B6, Vitamin B12. Liquid IV packets contain: sodium and potassium.
|
Outcome Measures
Primary Outcome Measures
- Alanine transaminase [baseline]
Alanine transaminase measured as part of metabolic panel with units IU/L
- Alanine transaminase [2 weeks of assigned treatment]
Alanine transaminase measured as part of metabolic panel with units IU/L
- Alanine transaminase [4 weeks of assigned treatment]
Alanine transaminase measured as part of metabolic panel with units IU/L
- Aspartate transferase [baseline]
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
- Aspartate transferase [2 weeks of assigned treatment]
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
- Aspartate transferase [4 weeks of assigned treatment]
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
- Albumin [baseline]
Albumin measured as part of comprehensive metabolic panel with units g/dL
- Albumin [2 weeks of assigned treatment]
Albumin measured as part of comprehensive metabolic panel with units g/dL
- Albumin [4 weeks of assigned treatment]
Albumin measured as part of comprehensive metabolic panel with units g/dL
- Alkaline phosphatase [baseline]
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
- Alkaline phosphatase [2 weeks of assigned treatment]
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
- Alkaline phosphatase [4 weeks of assigned treatment]
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
- total bilirubin [baseline]
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
- total bilirubin [2 weeks of assigned treatment]
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
- total bilirubin [4 weeks of assigned treatment]
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
- blood urea nitrogen mg/dL [baseline]
blood urea nitrogen as part of comprehensive metabolic panel with unite
- blood urea nitrogen [2 weeks of assigned treatment]
blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL
- blood urea nitrogen [4 weeks of assigned treatment]
blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL
- calcium [baseline]
calcium as part of comprehensive metabolic panel with units mg/dL
- calcium [2 weeks of assigned treatment]
calcium as part of comprehensive metabolic panel with units mg/dL
- calcium [4 weeks of assigned treatment]
calcium as part of comprehensive metabolic panel with units mg/dL
- carbon dioxide [baseline]
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
- carbon dioxide [2 weeks of assigned treatment]
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
- carbon dioxide [4 weeks of assigned treatment]
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
- chloride [baseline]
chloride as part of comprehensive metabolic panel with units mmol/L
- chloride [2 weeks of assigned treatment]
chloride as part of comprehensive metabolic panel with units mmol/L
- chloride [4 weeks of assigned treatment]
chloride as part of comprehensive metabolic panel with units mmol/L
- creatinine [baseline]
creatinine as part of comprehensive metabolic panel with units mg/dL
- creatinine [2 weeks of assigned treatment]
creatinine as part of comprehensive metabolic panel with units mg/dL
- creatinine [4 weeks of assigned treatment]
creatinine as part of comprehensive metabolic panel with units mg/dL
- estimated glomerular filtration rate calculation [baseline]
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
- estimated glomerular filtration rate calculation [2 weeks of assigned treatment]
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
- estimated glomerular filtration rate calculation [4 weeks of assigned treatment]
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
- blood glucose [baseline]
glucose as part of comprehensive metabolic panel with units mg/dL
- blood glucose [2 weeks of assigned treatment]
glucose as part of comprehensive metabolic panel with units mg/dL
- blood glucose [4 weeks of assigned treatment]
glucose as part of comprehensive metabolic panel with units mg/dL
- potassium [baseline]
potassium as part of comprehensive metabolic panel with units mmol/L
- potassium [2 weeks of assigned treatment]
potassium as part of comprehensive metabolic panel with units mmol/L
- potassium [4 weeks of assigned treatment]
potassium as part of comprehensive metabolic panel with units mmol/L
- total protein as part of comprehensive metabolic panel with units g/dL [baseline]
total protein
- total protein as part of comprehensive metabolic panel with units g/dL [2 weeks of assigned treatment]
total protein
- total protein as part of comprehensive metabolic panel with units g/dL [4 weeks of assigned treatment]
total protein
- sodium [baseline]
sodium as part of comprehensive metabolic panel with units mmol/L
- sodium [2 weeks of assigned treatment]
sodium as part of comprehensive metabolic panel with units mmol/L
- sodium [4 weeks of assigned treatment]
sodium as part of comprehensive metabolic panel with units mmol/L
- total globulin [baseline]
total globulin as part of comprehensive metabolic panel with units g/dL
- total globulin [2 weeks of assigned treatment]
total globulin as part of comprehensive metabolic panel with units g/dL
- total globulin [4 weeks of assigned treatment]
total globulin as part of comprehensive metabolic panel with units g/dL
- albumin/globulin ratio [baseline]
albumin/globulin ratio as part of comprehensive metabolic panel
- albumin/globulin ratio [2 weeks of assigned treatment]
albumin/globulin ratio as part of comprehensive metabolic panel
- albumin/globulin ratio [4 weeks of assigned treatment]
albumin/globulin ratio as part of comprehensive metabolic panel
- blood urea nitrogen/creatinine ratio [baseline]
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
- blood urea nitrogen/creatinine ratio [2 weeks of assigned treatment]
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
- blood urea nitrogen/creatinine ratio [4 weeks of assigned treatment]
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
- Hematocrit [baseline]
Hematocrit as part of complete blood count panel with differential test measured as percentage
- Hematocrit [2 weeks of assigned treatment]
Hematocrit as part of complete blood count panel with differential test measured as percentage
- Hematocrit [4 weeks of assigned treatment]
Hematocrit as part of complete blood count panel with differential test measured as percentage
- hemoglobin [baseline]
hemoglobin as part of complete blood count panel with differential test measured as g/dL
- hemoglobin [2 weeks of assigned treatment]
hemoglobin as part of complete blood count panel with differential test measured as g/dL
- hemoglobin [4 weeks of assigned treatment]
hemoglobin as part of complete blood count panel with differential test measured as g/dL
- mean corpuscular volume [baseline]
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
- mean corpuscular volume [2 weeks of assigned treatment]
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
- mean corpuscular volume [4 weeks of assigned treatment]
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
- mean corpuscular hemoglobin concentration [baseline]
mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL
- mean corpuscular hemoglobin concentration [2 weeks of assigned treatment]
mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL
- mean corpuscular hemoglobin concentration [4 weeks of assigned treatment]
mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL
- White blood cell distribution (absolute) [baseline]
absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel
- White blood cell distribution (absolute) [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
- White blood cell distribution (absolute) [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
- White blood cell distribution (percentage) [baseline]
percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.
- White blood cell distribution (percentage) [2 weeks of assigned treatment]
percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.
- White blood cell distribution (percentage) [4 weeks of assigned treatment]
percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.
- Red cell distribution width [baseline]
red cell distribution width as part of complete blood count panel with differential test measured as percentage
- Red cell distribution width [2 weeks of assigned treatment]
red cell distribution width as part of complete blood count panel with differential test measured as percentage
- Red cell distribution width [4 weeks of assigned treatment]
red cell distribution width as part of complete blood count panel with differential test measured as percentage
- platelet count [baseline]
platelet count per microliter as part of complete blood count panel with differential test
- platelet count [2 weeks of assigned treatment]
platelet count per microliter as part of complete blood count panel with differential test
- platelet count [4 weeks of assigned treatment]
platelet count per microliter as part of complete blood count panel with differential test
- red cell count [baseline]
red cell count per microliter as part of complete blood count panel with differential test
- red cell count [2 weeks of assigned treatment]
red cell count per microliter as part of complete blood count panel with differential test
- red cell count [4 weeks of assigned treatment]
red cell count per microliter as part of complete blood count panel with differential test
- white cell count [baseline]
white cell count per microliter as part of complete blood count panel with differential test
- white cell count [2 weeks of assigned treatment]
white cell count per microliter as part of complete blood count panel with differential test
- white cell count [4 weeks of assigned treatment]
white cell count per microliter as part of complete blood count panel with differential test
- Triiodothyronine [baseline]
Triiodothyronine measured in blood as ng/dL
- Triiodothyronine [2 weeks of assigned treatment]
Triiodothyronine measured in blood as ng/dL
- Triiodothyronine [4 weeks of assigned treatment]
Triiodothyronine measured in blood as ng/dL
- Thyroxine [baseline]
Thyroxine measured in blood as ug/dL
- Thyroxine [2 weeks of assigned treatment]
Thyroxine ug/dL measured in blood as ug/dL
- Thyroxine [4 weeks of assigned treatment]
Thyroxine ug/dL measured in blood as ug/dL
- thyroid stimulating hormone [baseline]
Thyroxine measured in blood as micro-IU/dL
- thyroid stimulating hormone [2 weeks of assigned treatment]
Thyroxine measured in blood as micro-IU/dL
- thyroid stimulating hormone [4 weeks of assigned treatment]
Thyroxine measured in blood as micro-IU/dL
- Urine Color [baseline]
Urine color as reported in complete urinalysis
- Urine Color [2 weeks of assigned treatment]
Urine color as reported in complete urinalysis
- Urine Color [4 weeks of assigned treatment]
Urine color as reported in complete urinalysis
- Urine appearance [baseline]
Urine appearance as reported in complete urinalysis
- Urine appearance [2 weeks of assigned treatment]
Urine appearance as reported in complete urinalysis
- Urine appearance [4 weeks of assigned treatment]
Urine appearance as reported in complete urinalysis
- Urine specific gravity [baseline]
Urine specific gravity as reported in complete urinalysis
- Urine specific gravity [2 weeks of assigned treatment]
Urine specific gravity as reported in complete urinalysis
- Urine specific gravity [4 weeks of assigned treatment]
Urine specific gravity as reported in complete urinalysis
- Urine potential of hydrogen [baseline]
Urine potential of hydrogen (pH) as reported in complete urinalysis
- Urine potential of hydrogen [2 weeks of assigned treatment]
Urine potential of hydrogen (pH) as reported in complete urinalysis
- Urine potential of hydrogen [4 weeks of assigned treatment]
Urine potential of hydrogen (pH) as reported in complete urinalysis
- Protein in urine [baseline]
Protein, if present, measured in urine in complete urinalysis
- Protein in urine [2 weeks of assigned treatment]
Protein, if present, measured in urine in complete urinalysis
- Protein in urine [4 weeks of assigned treatment]
Protein, if present, measured in urine in complete urinalysis
- Glucose in urine [baseline]
Glucose, if present, measured in urine in complete urinalysis
- Glucose in urine [2 weeks of assigned treatment]
Glucose, if present, measured in urine in complete urinalysis
- Glucose in urine [4 weeks of assigned treatment]
Glucose, if present, measured in urine in complete urinalysis
- Ketones in urine [baseline]
Ketones, if present, measured in urine in complete urinalysis
- Ketones in urine [2 weeks of assigned treatment]
Ketones, if present, measured in urine in complete urinalysis
- Ketones in urine [4 weeks of assigned treatment]
Ketones, if present, measured in urine in complete urinalysis
- Occult blood in urine [baseline]
Occult blood, if present, measured in urine in complete urinalysis
- Occult blood in urine [2 weeks of assigned treatment]
Occult blood, if present, measured in urine in complete urinalysis
- Occult blood in urine [4 weeks of assigned treatment]
Occult blood, if present, measured in urine in complete urinalysis
- White blood cell esterase in urine [baseline]
White blood cell esterase, if present, measured in urine
- White blood cell esterase in urine [2 weeks of assigned treatment]
White blood cell esterase, if present, measured in urine
- White blood cell esterase in urine [4 weeks of assigned treatment]
White blood cell esterase, if present, measured in urine
- Urine nitrite [baseline]
nitrite, if present, measured in urine
- Urine nitrite [2 weeks of assigned treatment]
nitrite, if present, measured in urine
- Urine nitrite [4 weeks of assigned treatment]
nitrite, if present, measured in urine
- bilirubin in urine [baseline]
bilirubin, if present, measured in urine
- bilirubin in urine [2 weeks of assigned treatment]
bilirubin, if present, measured in urine
- bilirubin in urine [4 weeks of assigned treatment]
bilirubin, if present, measured in urine
- urobilinogen in urine [baseline]
urobilinogen in urine measured in urinalysis as mg/dL
- urobilinogen in urine [2 weeks of assigned treatment]
urobilinogen in urine measured in urinalysis as mg/dL
- urobilinogen in urine [4 weeks of assigned treatment]
urobilinogen in urine measured in urinalysis as mg/dL
- Heart Rate [baseline]
Heart Rate measured using an automated blood pressure machine
- Heart Rate [2 weeks of assigned treatment]
Heart rate measured using an automated blood pressure machine
- Heart Rate [4 weeks of assigned treatment]
Heart rate measured using an automated blood pressure machine
- Blood Pressure [baseline]
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
- Blood Pressure [2 weeks of assigned treatment]
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
- Blood Pressure [4 weeks of assigned treatment]
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
- Product Tolerability questionnaire (gastrointestinal) [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)
- Product Tolerability questionnaire (gastrointestinal) [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)
- Product Tolerability questionnaire (gastrointestinal) [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)
- Product Tolerability questionnaire (consumption) [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.
- Product Tolerability questionnaire (consumption) [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.
- Product Tolerability questionnaire (consumption) [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.
- tolerability questionnaire [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)
- Daily food diary [3 days before baseline visit]
A list of all food and drink consumed that day
- tolerability questionnaire [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)
- Daily food diary [2 days before baseline visit]
A list of all food and drink consumed that day
- tolerability questionnaire [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)
- Daily food diary [1 day before baseline visit]
A list of all food and drink consumed that day
- tolerability questionnaire [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)
- Daily food diary [3 days before 2 week visit]
A list of all food and drink consumed that day
- Daily food diary [2 days before 2 week visit]
A list of all food and drink consumed that day
- tolerability questionnaire [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)
- tolerability questionnaire [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)
- Daily food diary [1 day before 2 week visit]
A list of all food and drink consumed that day
- tolerability questionnaire [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)
- Daily food diary [3 days before 4 week visit]
A list of all food and drink consumed that day
- tolerability questionnaire [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)
- Daily food diary [2 days before 4 week visit]
A list of all food and drink consumed that day
- tolerability questionnaire [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)
- Daily food diary [1 day before 4 week visit]
A list of all food and drink consumed that day
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Nutraceutical and Dietary Supplement Research | Memphis | Tennessee | United States | 38152 |
Sponsors and Collaborators
- University of Memphis
- Unilever R&D
Investigators
- Principal Investigator: Richard Bloomer, PhD, University of Memphis
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO-FY2023-5