NCT05592951

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

October 17, 2022

Last Update Submit

September 22, 2023

Conditions

Keywords

Liquid IVamino acidselectrolytes

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 COMPARATOR

1 stick pack dissolved in water once daily prior to breakfast

Dietary Supplement: Crystal Light (once serving)

Test beverage once daily

EXPERIMENTAL

1 stick pack dissolved in water once daily prior to breakfast

Dietary Supplement: Liquid IV with amino acids (one serving)

Test beverage twice daily

EXPERIMENTAL

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)

Test beverage three times daily

EXPERIMENTAL

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)

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.

Placebo once daily

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.

Test beverage once daily

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.

Test beverage twice daily

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.

Test beverage three times daily

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Interventions

Amino Acids

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • Richard Bloomer, PhD

    University of Memphis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized, placebo controlled study
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

Locations