Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers
Randomized Trial to Assess the Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2022
CompletedFirst Submitted
Initial submission to the registry
October 17, 2022
CompletedFirst Posted
Study publicly available on registry
October 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2023
CompletedSeptember 26, 2023
September 1, 2023
10 months
October 17, 2022
September 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (159)
Alanine transaminase
Alanine transaminase measured as part of metabolic panel with units IU/L
baseline
Alanine transaminase
Alanine transaminase measured as part of metabolic panel with units IU/L
2 weeks of assigned treatment
Alanine transaminase
Alanine transaminase measured as part of metabolic panel with units IU/L
4 weeks of assigned treatment
Aspartate transferase
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
baseline
Aspartate transferase
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
2 weeks of assigned treatment
Aspartate transferase
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
4 weeks of assigned treatment
Albumin
Albumin measured as part of comprehensive metabolic panel with units g/dL
baseline
Albumin
Albumin measured as part of comprehensive metabolic panel with units g/dL
2 weeks of assigned treatment
Albumin
Albumin measured as part of comprehensive metabolic panel with units g/dL
4 weeks of assigned treatment
Alkaline phosphatase
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
baseline
Alkaline phosphatase
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
2 weeks of assigned treatment
Alkaline phosphatase
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
4 weeks of assigned treatment
total bilirubin
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
baseline
total bilirubin
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
2 weeks of assigned treatment
total bilirubin
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
4 weeks of assigned treatment
blood urea nitrogen mg/dL
blood urea nitrogen as part of comprehensive metabolic panel with unite
baseline
blood urea nitrogen
blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL
2 weeks of assigned treatment
blood urea nitrogen
blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL
4 weeks of assigned treatment
calcium
calcium as part of comprehensive metabolic panel with units mg/dL
baseline
calcium
calcium as part of comprehensive metabolic panel with units mg/dL
2 weeks of assigned treatment
calcium
calcium as part of comprehensive metabolic panel with units mg/dL
4 weeks of assigned treatment
carbon dioxide
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
baseline
carbon dioxide
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
2 weeks of assigned treatment
carbon dioxide
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
4 weeks of assigned treatment
chloride
chloride as part of comprehensive metabolic panel with units mmol/L
baseline
chloride
chloride as part of comprehensive metabolic panel with units mmol/L
2 weeks of assigned treatment
chloride
chloride as part of comprehensive metabolic panel with units mmol/L
4 weeks of assigned treatment
creatinine
creatinine as part of comprehensive metabolic panel with units mg/dL
baseline
creatinine
creatinine as part of comprehensive metabolic panel with units mg/dL
2 weeks of assigned treatment
creatinine
creatinine as part of comprehensive metabolic panel with units mg/dL
4 weeks of assigned treatment
estimated glomerular filtration rate calculation
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
baseline
estimated glomerular filtration rate calculation
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
2 weeks of assigned treatment
estimated glomerular filtration rate calculation
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
4 weeks of assigned treatment
blood glucose
glucose as part of comprehensive metabolic panel with units mg/dL
baseline
blood glucose
glucose as part of comprehensive metabolic panel with units mg/dL
2 weeks of assigned treatment
blood glucose
glucose as part of comprehensive metabolic panel with units mg/dL
4 weeks of assigned treatment
potassium
potassium as part of comprehensive metabolic panel with units mmol/L
baseline
potassium
potassium as part of comprehensive metabolic panel with units mmol/L
2 weeks of assigned treatment
potassium
potassium as part of comprehensive metabolic panel with units mmol/L
4 weeks of assigned treatment
total protein as part of comprehensive metabolic panel with units g/dL
total protein
baseline
total protein as part of comprehensive metabolic panel with units g/dL
total protein
2 weeks of assigned treatment
total protein as part of comprehensive metabolic panel with units g/dL
total protein
4 weeks of assigned treatment
sodium
sodium as part of comprehensive metabolic panel with units mmol/L
baseline
sodium
sodium as part of comprehensive metabolic panel with units mmol/L
2 weeks of assigned treatment
sodium
sodium as part of comprehensive metabolic panel with units mmol/L
4 weeks of assigned treatment
total globulin
total globulin as part of comprehensive metabolic panel with units g/dL
baseline
total globulin
total globulin as part of comprehensive metabolic panel with units g/dL
2 weeks of assigned treatment
total globulin
total globulin as part of comprehensive metabolic panel with units g/dL
4 weeks of assigned treatment
albumin/globulin ratio
albumin/globulin ratio as part of comprehensive metabolic panel
baseline
albumin/globulin ratio
albumin/globulin ratio as part of comprehensive metabolic panel
2 weeks of assigned treatment
albumin/globulin ratio
albumin/globulin ratio as part of comprehensive metabolic panel
4 weeks of assigned treatment
blood urea nitrogen/creatinine ratio
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
baseline
blood urea nitrogen/creatinine ratio
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
2 weeks of assigned treatment
blood urea nitrogen/creatinine ratio
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
4 weeks of assigned treatment
Hematocrit
Hematocrit as part of complete blood count panel with differential test measured as percentage
baseline
Hematocrit
Hematocrit as part of complete blood count panel with differential test measured as percentage
2 weeks of assigned treatment
Hematocrit
Hematocrit as part of complete blood count panel with differential test measured as percentage
4 weeks of assigned treatment
hemoglobin
hemoglobin as part of complete blood count panel with differential test measured as g/dL
baseline
hemoglobin
hemoglobin as part of complete blood count panel with differential test measured as g/dL
2 weeks of assigned treatment
hemoglobin
hemoglobin as part of complete blood count panel with differential test measured as g/dL
4 weeks of assigned treatment
mean corpuscular volume
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
baseline
mean corpuscular volume
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
2 weeks of assigned treatment
mean corpuscular volume
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
4 weeks of assigned treatment
mean corpuscular hemoglobin concentration
mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL
baseline
mean corpuscular hemoglobin concentration
mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL
2 weeks of assigned treatment
mean corpuscular hemoglobin concentration
mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL
4 weeks of assigned treatment
White blood cell distribution (absolute)
absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel
baseline
White blood cell distribution (absolute)
absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel
2 weeks of assigned treatment
White blood cell distribution (absolute)
absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel
4 weeks of assigned treatment
White blood cell distribution (percentage)
percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.
baseline
White blood cell distribution (percentage)
percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.
2 weeks of assigned treatment
White blood cell distribution (percentage)
percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.
4 weeks of assigned treatment
Red cell distribution width
red cell distribution width as part of complete blood count panel with differential test measured as percentage
baseline
Red cell distribution width
red cell distribution width as part of complete blood count panel with differential test measured as percentage
2 weeks of assigned treatment
Red cell distribution width
red cell distribution width as part of complete blood count panel with differential test measured as percentage
4 weeks of assigned treatment
platelet count
platelet count per microliter as part of complete blood count panel with differential test
baseline
platelet count
platelet count per microliter as part of complete blood count panel with differential test
2 weeks of assigned treatment
platelet count
platelet count per microliter as part of complete blood count panel with differential test
4 weeks of assigned treatment
red cell count
red cell count per microliter as part of complete blood count panel with differential test
baseline
red cell count
red cell count per microliter as part of complete blood count panel with differential test
2 weeks of assigned treatment
red cell count
red cell count per microliter as part of complete blood count panel with differential test
4 weeks of assigned treatment
white cell count
white cell count per microliter as part of complete blood count panel with differential test
baseline
white cell count
white cell count per microliter as part of complete blood count panel with differential test
2 weeks of assigned treatment
white cell count
white cell count per microliter as part of complete blood count panel with differential test
4 weeks of assigned treatment
Triiodothyronine
Triiodothyronine measured in blood as ng/dL
baseline
Triiodothyronine
Triiodothyronine measured in blood as ng/dL
2 weeks of assigned treatment
Triiodothyronine
Triiodothyronine measured in blood as ng/dL
4 weeks of assigned treatment
Thyroxine
Thyroxine measured in blood as ug/dL
baseline
Thyroxine
Thyroxine ug/dL measured in blood as ug/dL
2 weeks of assigned treatment
Thyroxine
Thyroxine ug/dL measured in blood as ug/dL
4 weeks of assigned treatment
thyroid stimulating hormone
Thyroxine measured in blood as micro-IU/dL
baseline
thyroid stimulating hormone
Thyroxine measured in blood as micro-IU/dL
2 weeks of assigned treatment
thyroid stimulating hormone
Thyroxine measured in blood as micro-IU/dL
4 weeks of assigned treatment
Urine Color
Urine color as reported in complete urinalysis
baseline
Urine Color
Urine color as reported in complete urinalysis
2 weeks of assigned treatment
Urine Color
Urine color as reported in complete urinalysis
4 weeks of assigned treatment
Urine appearance
Urine appearance as reported in complete urinalysis
baseline
Urine appearance
Urine appearance as reported in complete urinalysis
2 weeks of assigned treatment
Urine appearance
Urine appearance as reported in complete urinalysis
4 weeks of assigned treatment
Urine specific gravity
Urine specific gravity as reported in complete urinalysis
baseline
Urine specific gravity
Urine specific gravity as reported in complete urinalysis
2 weeks of assigned treatment
Urine specific gravity
Urine specific gravity as reported in complete urinalysis
4 weeks of assigned treatment
Urine potential of hydrogen
Urine potential of hydrogen (pH) as reported in complete urinalysis
baseline
Urine potential of hydrogen
Urine potential of hydrogen (pH) as reported in complete urinalysis
2 weeks of assigned treatment
Urine potential of hydrogen
Urine potential of hydrogen (pH) as reported in complete urinalysis
4 weeks of assigned treatment
Protein in urine
Protein, if present, measured in urine in complete urinalysis
baseline
Protein in urine
Protein, if present, measured in urine in complete urinalysis
2 weeks of assigned treatment
Protein in urine
Protein, if present, measured in urine in complete urinalysis
4 weeks of assigned treatment
Glucose in urine
Glucose, if present, measured in urine in complete urinalysis
baseline
Glucose in urine
Glucose, if present, measured in urine in complete urinalysis
2 weeks of assigned treatment
Glucose in urine
Glucose, if present, measured in urine in complete urinalysis
4 weeks of assigned treatment
Ketones in urine
Ketones, if present, measured in urine in complete urinalysis
baseline
Ketones in urine
Ketones, if present, measured in urine in complete urinalysis
2 weeks of assigned treatment
Ketones in urine
Ketones, if present, measured in urine in complete urinalysis
4 weeks of assigned treatment
Occult blood in urine
Occult blood, if present, measured in urine in complete urinalysis
baseline
Occult blood in urine
Occult blood, if present, measured in urine in complete urinalysis
2 weeks of assigned treatment
Occult blood in urine
Occult blood, if present, measured in urine in complete urinalysis
4 weeks of assigned treatment
White blood cell esterase in urine
White blood cell esterase, if present, measured in urine
baseline
White blood cell esterase in urine
White blood cell esterase, if present, measured in urine
2 weeks of assigned treatment
White blood cell esterase in urine
White blood cell esterase, if present, measured in urine
4 weeks of assigned treatment
Urine nitrite
nitrite, if present, measured in urine
baseline
Urine nitrite
nitrite, if present, measured in urine
2 weeks of assigned treatment
Urine nitrite
nitrite, if present, measured in urine
4 weeks of assigned treatment
bilirubin in urine
bilirubin, if present, measured in urine
baseline
bilirubin in urine
bilirubin, if present, measured in urine
2 weeks of assigned treatment
bilirubin in urine
bilirubin, if present, measured in urine
4 weeks of assigned treatment
urobilinogen in urine
urobilinogen in urine measured in urinalysis as mg/dL
baseline
urobilinogen in urine
urobilinogen in urine measured in urinalysis as mg/dL
2 weeks of assigned treatment
urobilinogen in urine
urobilinogen in urine measured in urinalysis as mg/dL
4 weeks of assigned treatment
Heart Rate
Heart Rate measured using an automated blood pressure machine
baseline
Heart Rate
Heart rate measured using an automated blood pressure machine
2 weeks of assigned treatment
Heart Rate
Heart rate measured using an automated blood pressure machine
4 weeks of assigned treatment
Blood Pressure
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
baseline
Blood Pressure
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
2 weeks of assigned treatment
Blood Pressure
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
4 weeks of assigned treatment
Product Tolerability questionnaire (gastrointestinal)
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the past two weeks from 0 (None) to 10 (severe)
baseline
Product Tolerability questionnaire (gastrointestinal)
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the past two weeks from 0 (None) to 10 (severe)
2 weeks of assigned treatment
Product Tolerability questionnaire (gastrointestinal)
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the past two weeks from 0 (None) to 10 (severe)
4 weeks of assigned treatment
Product Tolerability questionnaire (consumption)
Questionnaire that can be scored 1-5 (1 bad quality to 5 good quality): answers of strongly agree, agree, neutral, disagree, and strongly agree for tastes pleasant, easy to drink, easy on stomach, would purchase, dissolves easily, too gritty, too sticky and excessively, mildly too much, optimal, mildly too little, and extremely lacking for sweet, sour, salty, bitter. Final question on after taste with answers of pleasant, ok, no taste, unpleasant, extremely unpleasant.
baseline
Product Tolerability questionnaire (consumption)
Questionnaire that can be scored 1-5 (1 bad quality to 5 good quality): with answers of strongly agree, agree, neutral, disagree, and strongly agree for tastes pleasant, easy to drink, easy on stomach, would purchase, dissolves easily, too gritty, too sticky and excessively, mildly too much, optimal, mildly too little, and extremely lacking for sweet, sour, salty, bitter. Final question on after taste with answers of pleasant, ok, no taste, unpleasant, extremely unpleasant.
2 weeks of assigned treatment
Product Tolerability questionnaire (consumption)
Questionnaire that can be scored 1-5 (1 bad quality to 5 good quality): with answers of strongly agree, agree, neutral, disagree, and strongly agree for tastes pleasant, easy to drink, easy on stomach, would purchase, dissolves easily, too gritty, too sticky and excessively, mildly too much, optimal, mildly too little, and extremely lacking for sweet, sour, salty, bitter. Final question on after taste with answers of pleasant, ok, no taste, unpleasant, extremely unpleasant.
4 weeks of assigned treatment visit
tolerability questionnaire
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
3 days before baseline visit
Daily food diary
A list of all food and drink consumed that day
3 days before baseline visit
tolerability questionnaire
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
2 days before baseline visit
Daily food diary
A list of all food and drink consumed that day
2 days before baseline visit
tolerability questionnaire
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
1 day before baseline visit
Daily food diary
A list of all food and drink consumed that day
1 day before baseline visit
tolerability questionnaire
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
3 days before 2 week visit
Daily food diary
A list of all food and drink consumed that day
3 days before 2 week visit
Daily food diary
A list of all food and drink consumed that day
2 days before 2 week visit
tolerability questionnaire
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
2 days before 2 week visit
tolerability questionnaire
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
1 day before 2 week visit
Daily food diary
A list of all food and drink consumed that day
1 day before 2 week visit
tolerability questionnaire
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
3 days before 4 week visit
Daily food diary
A list of all food and drink consumed that day
3 days before 4 week visit
tolerability questionnaire
A list of all food and drink consumed that day along with a Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
2 days before 4 week visit
Daily food diary
A list of all food and drink consumed that day
2 days before 4 week visit
tolerability questionnaire
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
1 day before 4 week visit
Daily food diary
A list of all food and drink consumed that day
1 day before 4 week visit
Study Arms (4)
Placebo once daily
PLACEBO COMPARATOR1 stick pack dissolved in water once daily prior to breakfast
Test beverage once daily
EXPERIMENTAL1 stick pack dissolved in water once daily prior to breakfast
Test beverage twice daily
EXPERIMENTAL2 stick packs dissolved in water, one packet at a time twice daily (after lunch and after dinner)
Test beverage three times daily
EXPERIMENTAL3 stick packs dissolved in water, one packet at a time three times daily (after breakfast, lunch, and dinner)
Interventions
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.
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) between 18-29.9 kg/m2
- able to fast overnight
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Memphislead
- Unilever R&Dcollaborator
Study Sites (1)
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38152, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Bloomer, PhD
University of Memphis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dean of the College of Health Sciences
Study Record Dates
First Submitted
October 17, 2022
First Posted
October 25, 2022
Study Start
September 30, 2022
Primary Completion
July 14, 2023
Study Completion
July 18, 2023
Last Updated
September 26, 2023
Record last verified: 2023-09