Randomized Trial to Assess the Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- thyroid stimulating hormone
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) between 18-29.9 kg/m2
- •able to fast overnight
排除标准
- •tobacco user
- •history of heart disease/cardiovascular disease
- •hypertensive (140/90 mmHg or less)
- •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
研究组 & 干预措施
Placebo once daily
1 stick pack dissolved in water once daily prior to breakfast
干预措施: Crystal Light (once serving) (Dietary Supplement)
Test beverage once daily
1 stick pack dissolved in water once daily prior to breakfast
干预措施: Liquid IV with amino acids (one serving) (Dietary Supplement)
Test beverage twice daily
2 stick packs dissolved in water, one packet at a time twice daily (after lunch and after dinner)
干预措施: Liquid IV with amino acids (two servings) (Dietary Supplement)
Test beverage three times daily
3 stick packs dissolved in water, one packet at a time three times daily (after breakfast, lunch, and dinner)
干预措施: Liquid IV with amino acids (three servings) (Dietary Supplement)
结局指标
主要结局
thyroid stimulating hormone
时间窗: 4 weeks of assigned treatment
Thyroxine measured in blood as micro-IU/dL
total protein as part of comprehensive metabolic panel with units g/dL
时间窗: 4 weeks of assigned treatment
total protein
total globulin
时间窗: 4 weeks of assigned treatment
total globulin as part of comprehensive metabolic panel with units g/dL
Blood Pressure
时间窗: 4 weeks of assigned treatment
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
Alanine transaminase
时间窗: 4 weeks of assigned treatment
Alanine transaminase measured as part of metabolic panel with units IU/L
Aspartate transferase
时间窗: 4 weeks of assigned treatment
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
Alkaline phosphatase
时间窗: 4 weeks of assigned treatment
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
chloride
时间窗: 4 weeks of assigned treatment
chloride as part of comprehensive metabolic panel with units mmol/L
potassium
时间窗: 4 weeks of assigned treatment
potassium as part of comprehensive metabolic panel with units mmol/L
sodium
时间窗: 4 weeks of assigned treatment
sodium as part of comprehensive metabolic panel with units mmol/L
total bilirubin
时间窗: 4 weeks of assigned treatment
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
blood urea nitrogen mg/dL
时间窗: baseline
blood urea nitrogen as part of comprehensive metabolic panel with unite
blood urea nitrogen
时间窗: 4 weeks of assigned treatment
blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL
calcium
时间窗: 4 weeks of assigned treatment
calcium as part of comprehensive metabolic panel with units mg/dL
White blood cell distribution (absolute)
时间窗: 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
Red cell distribution width
时间窗: 4 weeks of assigned treatment
red cell distribution width as part of complete blood count panel with differential test measured as percentage
platelet count
时间窗: 4 weeks of assigned treatment
platelet count per microliter as part of complete blood count panel with differential test
white cell count
时间窗: 4 weeks of assigned treatment
white cell count per microliter as part of complete blood count panel with differential test
Albumin
时间窗: 4 weeks of assigned treatment
Albumin measured as part of comprehensive metabolic panel with units g/dL
carbon dioxide
时间窗: 4 weeks of assigned treatment
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
blood glucose
时间窗: 4 weeks of assigned treatment
glucose as part of comprehensive metabolic panel with units mg/dL
hemoglobin
时间窗: 4 weeks of assigned treatment
hemoglobin as part of complete blood count panel with differential test measured as g/dL
Thyroxine
时间窗: 4 weeks of assigned treatment
Thyroxine ug/dL measured in blood as ug/dL
Urine potential of hydrogen
时间窗: 4 weeks of assigned treatment
Urine potential of hydrogen (pH) as reported in complete urinalysis
Protein in urine
时间窗: 4 weeks of assigned treatment
Protein, if present, measured in urine in complete urinalysis
Ketones in urine
时间窗: 4 weeks of assigned treatment
Ketones, if present, measured in urine in complete urinalysis
White blood cell esterase in urine
时间窗: 4 weeks of assigned treatment
White blood cell esterase, if present, measured in urine
Hematocrit
时间窗: 4 weeks of assigned treatment
Hematocrit as part of complete blood count panel with differential test measured as percentage
creatinine
时间窗: 4 weeks of assigned treatment
creatinine as part of comprehensive metabolic panel with units mg/dL
estimated glomerular filtration rate calculation
时间窗: 4 weeks of assigned treatment
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
albumin/globulin ratio
时间窗: 4 weeks of assigned treatment
albumin/globulin ratio as part of comprehensive metabolic panel
mean corpuscular hemoglobin concentration
时间窗: 4 weeks of assigned treatment
mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL
red cell count
时间窗: 4 weeks of assigned treatment
red cell count per microliter as part of complete blood count panel with differential test
Triiodothyronine
时间窗: 4 weeks of assigned treatment
Triiodothyronine measured in blood as ng/dL
urobilinogen in urine
时间窗: 4 weeks of assigned treatment
urobilinogen in urine measured in urinalysis as mg/dL
tolerability questionnaire
时间窗: 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)
blood urea nitrogen/creatinine ratio
时间窗: 4 weeks of assigned treatment
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
mean corpuscular volume
时间窗: 4 weeks of assigned treatment
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
White blood cell distribution (percentage)
时间窗: 4 weeks of assigned treatment
percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.
Urine appearance
时间窗: 4 weeks of assigned treatment
Urine appearance as reported in complete urinalysis
Urine specific gravity
时间窗: 4 weeks of assigned treatment
Urine specific gravity as reported in complete urinalysis
Glucose in urine
时间窗: 4 weeks of assigned treatment
Glucose, if present, measured in urine in complete urinalysis
Urine nitrite
时间窗: 4 weeks of assigned treatment
nitrite, if present, measured in urine
Heart Rate
时间窗: 4 weeks of assigned treatment
Heart rate measured using an automated blood pressure machine
Urine Color
时间窗: 4 weeks of assigned treatment
Urine color as reported in complete urinalysis
Occult blood in urine
时间窗: 4 weeks of assigned treatment
Occult blood, if present, measured in urine in complete urinalysis
bilirubin in urine
时间窗: 4 weeks of assigned treatment
bilirubin, if present, measured in urine
Product Tolerability questionnaire (gastrointestinal)
时间窗: 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)
时间窗: 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.
Daily food diary
时间窗: 1 day before 4 week visit
A list of all food and drink consumed that day
Urine Color
时间窗: 2 weeks of assigned treatment
Urine color as reported in complete urinalysis
Urine nitrite
时间窗: baseline
nitrite, if present, measured in urine
Alanine transaminase
时间窗: baseline
Alanine transaminase measured as part of metabolic panel with units IU/L
Alanine transaminase
时间窗: 2 weeks of assigned treatment
Alanine transaminase measured as part of metabolic panel with units IU/L
Aspartate transferase
时间窗: baseline
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
Aspartate transferase
时间窗: 2 weeks of assigned treatment
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
Albumin
时间窗: baseline
Albumin measured as part of comprehensive metabolic panel with units g/dL
Albumin
时间窗: 2 weeks of assigned treatment
Albumin measured as part of comprehensive metabolic panel with units g/dL
Alkaline phosphatase
时间窗: baseline
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
Alkaline phosphatase
时间窗: 2 weeks of assigned treatment
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
total bilirubin
时间窗: baseline
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
total bilirubin
时间窗: 2 weeks of assigned treatment
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
blood urea nitrogen
时间窗: 2 weeks of assigned treatment
blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL
calcium
时间窗: baseline
calcium as part of comprehensive metabolic panel with units mg/dL
calcium
时间窗: 2 weeks of assigned treatment
calcium as part of comprehensive metabolic panel with units mg/dL
carbon dioxide
时间窗: baseline
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
carbon dioxide
时间窗: 2 weeks of assigned treatment
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
chloride
时间窗: baseline
chloride as part of comprehensive metabolic panel with units mmol/L
chloride
时间窗: 2 weeks of assigned treatment
chloride as part of comprehensive metabolic panel with units mmol/L
creatinine
时间窗: baseline
creatinine as part of comprehensive metabolic panel with units mg/dL
creatinine
时间窗: 2 weeks of assigned treatment
creatinine as part of comprehensive metabolic panel with units mg/dL
estimated glomerular filtration rate calculation
时间窗: baseline
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
estimated glomerular filtration rate calculation
时间窗: 2 weeks of assigned treatment
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
blood glucose
时间窗: baseline
glucose as part of comprehensive metabolic panel with units mg/dL
blood glucose
时间窗: 2 weeks of assigned treatment
glucose as part of comprehensive metabolic panel with units mg/dL
potassium
时间窗: baseline
potassium as part of comprehensive metabolic panel with units mmol/L
potassium
时间窗: 2 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
时间窗: baseline
total protein
total protein as part of comprehensive metabolic panel with units g/dL
时间窗: 2 weeks of assigned treatment
total protein
sodium
时间窗: baseline
sodium as part of comprehensive metabolic panel with units mmol/L
sodium
时间窗: 2 weeks of assigned treatment
sodium as part of comprehensive metabolic panel with units mmol/L
total globulin
时间窗: baseline
total globulin as part of comprehensive metabolic panel with units g/dL
total globulin
时间窗: 2 weeks of assigned treatment
total globulin as part of comprehensive metabolic panel with units g/dL
albumin/globulin ratio
时间窗: baseline
albumin/globulin ratio as part of comprehensive metabolic panel
albumin/globulin ratio
时间窗: 2 weeks of assigned treatment
albumin/globulin ratio as part of comprehensive metabolic panel
blood urea nitrogen/creatinine ratio
时间窗: baseline
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
blood urea nitrogen/creatinine ratio
时间窗: 2 weeks of assigned treatment
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
Hematocrit
时间窗: baseline
Hematocrit as part of complete blood count panel with differential test measured as percentage
Hematocrit
时间窗: 2 weeks of assigned treatment
Hematocrit as part of complete blood count panel with differential test measured as percentage
hemoglobin
时间窗: baseline
hemoglobin as part of complete blood count panel with differential test measured as g/dL
hemoglobin
时间窗: 2 weeks of assigned treatment
hemoglobin as part of complete blood count panel with differential test measured as g/dL
mean corpuscular volume
时间窗: baseline
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
mean corpuscular volume
时间窗: 2 weeks of assigned treatment
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
mean corpuscular hemoglobin concentration
时间窗: baseline
mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL
mean corpuscular hemoglobin concentration
时间窗: 2 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)
时间窗: 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)
时间窗: 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 (percentage)
时间窗: 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)
时间窗: 2 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
时间窗: baseline
red cell distribution width as part of complete blood count panel with differential test measured as percentage
Red cell distribution width
时间窗: 2 weeks of assigned treatment
red cell distribution width as part of complete blood count panel with differential test measured as percentage
platelet count
时间窗: baseline
platelet count per microliter as part of complete blood count panel with differential test
platelet count
时间窗: 2 weeks of assigned treatment
platelet count per microliter as part of complete blood count panel with differential test
red cell count
时间窗: baseline
red cell count per microliter as part of complete blood count panel with differential test
red cell count
时间窗: 2 weeks of assigned treatment
red cell count per microliter as part of complete blood count panel with differential test
white cell count
时间窗: baseline
white cell count per microliter as part of complete blood count panel with differential test
white cell count
时间窗: 2 weeks of assigned treatment
white cell count per microliter as part of complete blood count panel with differential test
Triiodothyronine
时间窗: baseline
Triiodothyronine measured in blood as ng/dL
Triiodothyronine
时间窗: 2 weeks of assigned treatment
Triiodothyronine measured in blood as ng/dL
Thyroxine
时间窗: baseline
Thyroxine measured in blood as ug/dL
Thyroxine
时间窗: 2 weeks of assigned treatment
Thyroxine ug/dL measured in blood as ug/dL
thyroid stimulating hormone
时间窗: baseline
Thyroxine measured in blood as micro-IU/dL
thyroid stimulating hormone
时间窗: 2 weeks of assigned treatment
Thyroxine measured in blood as micro-IU/dL
Urine Color
时间窗: baseline
Urine color as reported in complete urinalysis
Urine appearance
时间窗: baseline
Urine appearance as reported in complete urinalysis
Urine appearance
时间窗: 2 weeks of assigned treatment
Urine appearance as reported in complete urinalysis
Urine specific gravity
时间窗: baseline
Urine specific gravity as reported in complete urinalysis
Urine specific gravity
时间窗: 2 weeks of assigned treatment
Urine specific gravity as reported in complete urinalysis
Urine potential of hydrogen
时间窗: baseline
Urine potential of hydrogen (pH) as reported in complete urinalysis
Urine potential of hydrogen
时间窗: 2 weeks of assigned treatment
Urine potential of hydrogen (pH) as reported in complete urinalysis
Protein in urine
时间窗: baseline
Protein, if present, measured in urine in complete urinalysis
Protein in urine
时间窗: 2 weeks of assigned treatment
Protein, if present, measured in urine in complete urinalysis
Glucose in urine
时间窗: baseline
Glucose, if present, measured in urine in complete urinalysis
Glucose in urine
时间窗: 2 weeks of assigned treatment
Glucose, if present, measured in urine in complete urinalysis
Ketones in urine
时间窗: baseline
Ketones, if present, measured in urine in complete urinalysis
Ketones in urine
时间窗: 2 weeks of assigned treatment
Ketones, if present, measured in urine in complete urinalysis
Occult blood in urine
时间窗: baseline
Occult blood, if present, measured in urine in complete urinalysis
Occult blood in urine
时间窗: 2 weeks of assigned treatment
Occult blood, if present, measured in urine in complete urinalysis
White blood cell esterase in urine
时间窗: baseline
White blood cell esterase, if present, measured in urine
White blood cell esterase in urine
时间窗: 2 weeks of assigned treatment
White blood cell esterase, if present, measured in urine
Urine nitrite
时间窗: 2 weeks of assigned treatment
nitrite, if present, measured in urine
bilirubin in urine
时间窗: baseline
bilirubin, if present, measured in urine
bilirubin in urine
时间窗: 2 weeks of assigned treatment
bilirubin, if present, measured in urine
urobilinogen in urine
时间窗: baseline
urobilinogen in urine measured in urinalysis as mg/dL
urobilinogen in urine
时间窗: 2 weeks of assigned treatment
urobilinogen in urine measured in urinalysis as mg/dL
Heart Rate
时间窗: baseline
Heart Rate measured using an automated blood pressure machine
Heart Rate
时间窗: 2 weeks of assigned treatment
Heart rate measured using an automated blood pressure machine
Blood Pressure
时间窗: baseline
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
Blood Pressure
时间窗: 2 weeks of assigned treatment
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
Product Tolerability questionnaire (gastrointestinal)
时间窗: 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)
时间窗: 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 (consumption)
时间窗: 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)
时间窗: 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.
tolerability questionnaire
时间窗: 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
时间窗: 3 days before baseline visit
A list of all food and drink consumed that day
tolerability questionnaire
时间窗: 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
时间窗: 2 days before baseline visit
A list of all food and drink consumed that day
tolerability questionnaire
时间窗: 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
时间窗: 1 day before baseline visit
A list of all food and drink consumed that day
tolerability questionnaire
时间窗: 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
时间窗: 3 days before 2 week visit
A list of all food and drink consumed that day
Daily food diary
时间窗: 2 days before 2 week visit
A list of all food and drink consumed that day
tolerability questionnaire
时间窗: 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
时间窗: 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
时间窗: 1 day before 2 week visit
A list of all food and drink consumed that day
tolerability questionnaire
时间窗: 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
时间窗: 3 days before 4 week visit
A list of all food and drink consumed that day
tolerability questionnaire
时间窗: 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
时间窗: 2 days before 4 week visit
A list of all food and drink consumed that day
次要结局
未报告次要终点
研究者
Richard Bloomer
Dean of the College of Health Sciences
University of Memphis