Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Alanine transaminase |
Alanine transaminase measured as part of metabolic panel with units IU/L |
baseline |
|
Primary |
Alanine transaminase |
Alanine transaminase measured as part of metabolic panel with units IU/L |
2 weeks of assigned treatment |
|
Primary |
Alanine transaminase |
Alanine transaminase measured as part of metabolic panel with units IU/L |
4 weeks of assigned treatment |
|
Primary |
Aspartate transferase |
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L |
baseline |
|
Primary |
Aspartate transferase |
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L |
2 weeks of assigned treatment |
|
Primary |
Aspartate transferase |
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L |
4 weeks of assigned treatment |
|
Primary |
Albumin |
Albumin measured as part of comprehensive metabolic panel with units g/dL |
baseline |
|
Primary |
Albumin |
Albumin measured as part of comprehensive metabolic panel with units g/dL |
2 weeks of assigned treatment |
|
Primary |
Albumin |
Albumin measured as part of comprehensive metabolic panel with units g/dL |
4 weeks of assigned treatment |
|
Primary |
Alkaline phosphatase |
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L |
baseline |
|
Primary |
Alkaline phosphatase |
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L |
2 weeks of assigned treatment |
|
Primary |
Alkaline phosphatase |
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L |
4 weeks of assigned treatment |
|
Primary |
total bilirubin |
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL |
baseline |
|
Primary |
total bilirubin |
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL |
2 weeks of assigned treatment |
|
Primary |
total bilirubin |
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL |
4 weeks of assigned treatment |
|
Primary |
blood urea nitrogen mg/dL |
blood urea nitrogen as part of comprehensive metabolic panel with unite |
baseline |
|
Primary |
blood urea nitrogen |
blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL |
2 weeks of assigned treatment |
|
Primary |
blood urea nitrogen |
blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL |
4 weeks of assigned treatment |
|
Primary |
calcium |
calcium as part of comprehensive metabolic panel with units mg/dL |
baseline |
|
Primary |
calcium |
calcium as part of comprehensive metabolic panel with units mg/dL |
2 weeks of assigned treatment |
|
Primary |
calcium |
calcium as part of comprehensive metabolic panel with units mg/dL |
4 weeks of assigned treatment |
|
Primary |
carbon dioxide |
carbon dioxide as part of comprehensive metabolic panel with units mmol/L |
baseline |
|
Primary |
carbon dioxide |
carbon dioxide as part of comprehensive metabolic panel with units mmol/L |
2 weeks of assigned treatment |
|
Primary |
carbon dioxide |
carbon dioxide as part of comprehensive metabolic panel with units mmol/L |
4 weeks of assigned treatment |
|
Primary |
chloride |
chloride as part of comprehensive metabolic panel with units mmol/L |
baseline |
|
Primary |
chloride |
chloride as part of comprehensive metabolic panel with units mmol/L |
2 weeks of assigned treatment |
|
Primary |
chloride |
chloride as part of comprehensive metabolic panel with units mmol/L |
4 weeks of assigned treatment |
|
Primary |
creatinine |
creatinine as part of comprehensive metabolic panel with units mg/dL |
baseline |
|
Primary |
creatinine |
creatinine as part of comprehensive metabolic panel with units mg/dL |
2 weeks of assigned treatment |
|
Primary |
creatinine |
creatinine as part of comprehensive metabolic panel with units mg/dL |
4 weeks of assigned treatment |
|
Primary |
estimated glomerular filtration rate calculation |
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73 |
baseline |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
blood glucose |
glucose as part of comprehensive metabolic panel with units mg/dL |
baseline |
|
Primary |
blood glucose |
glucose as part of comprehensive metabolic panel with units mg/dL |
2 weeks of assigned treatment |
|
Primary |
blood glucose |
glucose as part of comprehensive metabolic panel with units mg/dL |
4 weeks of assigned treatment |
|
Primary |
potassium |
potassium as part of comprehensive metabolic panel with units mmol/L |
baseline |
|
Primary |
potassium |
potassium as part of comprehensive metabolic panel with units mmol/L |
2 weeks of assigned treatment |
|
Primary |
potassium |
potassium as part of comprehensive metabolic panel with units mmol/L |
4 weeks of assigned treatment |
|
Primary |
total protein as part of comprehensive metabolic panel with units g/dL |
total protein |
baseline |
|
Primary |
total protein as part of comprehensive metabolic panel with units g/dL |
total protein |
2 weeks of assigned treatment |
|
Primary |
total protein as part of comprehensive metabolic panel with units g/dL |
total protein |
4 weeks of assigned treatment |
|
Primary |
sodium |
sodium as part of comprehensive metabolic panel with units mmol/L |
baseline |
|
Primary |
sodium |
sodium as part of comprehensive metabolic panel with units mmol/L |
2 weeks of assigned treatment |
|
Primary |
sodium |
sodium as part of comprehensive metabolic panel with units mmol/L |
4 weeks of assigned treatment |
|
Primary |
total globulin |
total globulin as part of comprehensive metabolic panel with units g/dL |
baseline |
|
Primary |
total globulin |
total globulin as part of comprehensive metabolic panel with units g/dL |
2 weeks of assigned treatment |
|
Primary |
total globulin |
total globulin as part of comprehensive metabolic panel with units g/dL |
4 weeks of assigned treatment |
|
Primary |
albumin/globulin ratio |
albumin/globulin ratio as part of comprehensive metabolic panel |
baseline |
|
Primary |
albumin/globulin ratio |
albumin/globulin ratio as part of comprehensive metabolic panel |
2 weeks of assigned treatment |
|
Primary |
albumin/globulin ratio |
albumin/globulin ratio as part of comprehensive metabolic panel |
4 weeks of assigned treatment |
|
Primary |
blood urea nitrogen/creatinine ratio |
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel |
baseline |
|
Primary |
blood urea nitrogen/creatinine ratio |
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel |
2 weeks of assigned treatment |
|
Primary |
blood urea nitrogen/creatinine ratio |
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel |
4 weeks of assigned treatment |
|
Primary |
Hematocrit |
Hematocrit as part of complete blood count panel with differential test measured as percentage |
baseline |
|
Primary |
Hematocrit |
Hematocrit as part of complete blood count panel with differential test measured as percentage |
2 weeks of assigned treatment |
|
Primary |
Hematocrit |
Hematocrit as part of complete blood count panel with differential test measured as percentage |
4 weeks of assigned treatment |
|
Primary |
hemoglobin |
hemoglobin as part of complete blood count panel with differential test measured as g/dL |
baseline |
|
Primary |
hemoglobin |
hemoglobin as part of complete blood count panel with differential test measured as g/dL |
2 weeks of assigned treatment |
|
Primary |
hemoglobin |
hemoglobin as part of complete blood count panel with differential test measured as g/dL |
4 weeks of assigned treatment |
|
Primary |
mean corpuscular volume |
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter |
baseline |
|
Primary |
mean corpuscular volume |
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter |
2 weeks of assigned treatment |
|
Primary |
mean corpuscular volume |
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter |
4 weeks of assigned treatment |
|
Primary |
mean corpuscular hemoglobin concentration |
mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL |
baseline |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
Red cell distribution width |
red cell distribution width as part of complete blood count panel with differential test measured as percentage |
baseline |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
platelet count |
platelet count per microliter as part of complete blood count panel with differential test |
baseline |
|
Primary |
platelet count |
platelet count per microliter as part of complete blood count panel with differential test |
2 weeks of assigned treatment |
|
Primary |
platelet count |
platelet count per microliter as part of complete blood count panel with differential test |
4 weeks of assigned treatment |
|
Primary |
red cell count |
red cell count per microliter as part of complete blood count panel with differential test |
baseline |
|
Primary |
red cell count |
red cell count per microliter as part of complete blood count panel with differential test |
2 weeks of assigned treatment |
|
Primary |
red cell count |
red cell count per microliter as part of complete blood count panel with differential test |
4 weeks of assigned treatment |
|
Primary |
white cell count |
white cell count per microliter as part of complete blood count panel with differential test |
baseline |
|
Primary |
white cell count |
white cell count per microliter as part of complete blood count panel with differential test |
2 weeks of assigned treatment |
|
Primary |
white cell count |
white cell count per microliter as part of complete blood count panel with differential test |
4 weeks of assigned treatment |
|
Primary |
Triiodothyronine |
Triiodothyronine measured in blood as ng/dL |
baseline |
|
Primary |
Triiodothyronine |
Triiodothyronine measured in blood as ng/dL |
2 weeks of assigned treatment |
|
Primary |
Triiodothyronine |
Triiodothyronine measured in blood as ng/dL |
4 weeks of assigned treatment |
|
Primary |
Thyroxine |
Thyroxine measured in blood as ug/dL |
baseline |
|
Primary |
Thyroxine |
Thyroxine ug/dL measured in blood as ug/dL |
2 weeks of assigned treatment |
|
Primary |
Thyroxine |
Thyroxine ug/dL measured in blood as ug/dL |
4 weeks of assigned treatment |
|
Primary |
thyroid stimulating hormone |
Thyroxine measured in blood as micro-IU/dL |
baseline |
|
Primary |
thyroid stimulating hormone |
Thyroxine measured in blood as micro-IU/dL |
2 weeks of assigned treatment |
|
Primary |
thyroid stimulating hormone |
Thyroxine measured in blood as micro-IU/dL |
4 weeks of assigned treatment |
|
Primary |
Urine Color |
Urine color as reported in complete urinalysis |
baseline |
|
Primary |
Urine Color |
Urine color as reported in complete urinalysis |
2 weeks of assigned treatment |
|
Primary |
Urine Color |
Urine color as reported in complete urinalysis |
4 weeks of assigned treatment |
|
Primary |
Urine appearance |
Urine appearance as reported in complete urinalysis |
baseline |
|
Primary |
Urine appearance |
Urine appearance as reported in complete urinalysis |
2 weeks of assigned treatment |
|
Primary |
Urine appearance |
Urine appearance as reported in complete urinalysis |
4 weeks of assigned treatment |
|
Primary |
Urine specific gravity |
Urine specific gravity as reported in complete urinalysis |
baseline |
|
Primary |
Urine specific gravity |
Urine specific gravity as reported in complete urinalysis |
2 weeks of assigned treatment |
|
Primary |
Urine specific gravity |
Urine specific gravity as reported in complete urinalysis |
4 weeks of assigned treatment |
|
Primary |
Urine potential of hydrogen |
Urine potential of hydrogen (pH) as reported in complete urinalysis |
baseline |
|
Primary |
Urine potential of hydrogen |
Urine potential of hydrogen (pH) as reported in complete urinalysis |
2 weeks of assigned treatment |
|
Primary |
Urine potential of hydrogen |
Urine potential of hydrogen (pH) as reported in complete urinalysis |
4 weeks of assigned treatment |
|
Primary |
Protein in urine |
Protein, if present, measured in urine in complete urinalysis |
baseline |
|
Primary |
Protein in urine |
Protein, if present, measured in urine in complete urinalysis |
2 weeks of assigned treatment |
|
Primary |
Protein in urine |
Protein, if present, measured in urine in complete urinalysis |
4 weeks of assigned treatment |
|
Primary |
Glucose in urine |
Glucose, if present, measured in urine in complete urinalysis |
baseline |
|
Primary |
Glucose in urine |
Glucose, if present, measured in urine in complete urinalysis |
2 weeks of assigned treatment |
|
Primary |
Glucose in urine |
Glucose, if present, measured in urine in complete urinalysis |
4 weeks of assigned treatment |
|
Primary |
Ketones in urine |
Ketones, if present, measured in urine in complete urinalysis |
baseline |
|
Primary |
Ketones in urine |
Ketones, if present, measured in urine in complete urinalysis |
2 weeks of assigned treatment |
|
Primary |
Ketones in urine |
Ketones, if present, measured in urine in complete urinalysis |
4 weeks of assigned treatment |
|
Primary |
Occult blood in urine |
Occult blood, if present, measured in urine in complete urinalysis |
baseline |
|
Primary |
Occult blood in urine |
Occult blood, if present, measured in urine in complete urinalysis |
2 weeks of assigned treatment |
|
Primary |
Occult blood in urine |
Occult blood, if present, measured in urine in complete urinalysis |
4 weeks of assigned treatment |
|
Primary |
White blood cell esterase in urine |
White blood cell esterase, if present, measured in urine |
baseline |
|
Primary |
White blood cell esterase in urine |
White blood cell esterase, if present, measured in urine |
2 weeks of assigned treatment |
|
Primary |
White blood cell esterase in urine |
White blood cell esterase, if present, measured in urine |
4 weeks of assigned treatment |
|
Primary |
Urine nitrite |
nitrite, if present, measured in urine |
baseline |
|
Primary |
Urine nitrite |
nitrite, if present, measured in urine |
2 weeks of assigned treatment |
|
Primary |
Urine nitrite |
nitrite, if present, measured in urine |
4 weeks of assigned treatment |
|
Primary |
bilirubin in urine |
bilirubin, if present, measured in urine |
baseline |
|
Primary |
bilirubin in urine |
bilirubin, if present, measured in urine |
2 weeks of assigned treatment |
|
Primary |
bilirubin in urine |
bilirubin, if present, measured in urine |
4 weeks of assigned treatment |
|
Primary |
urobilinogen in urine |
urobilinogen in urine measured in urinalysis as mg/dL |
baseline |
|
Primary |
urobilinogen in urine |
urobilinogen in urine measured in urinalysis as mg/dL |
2 weeks of assigned treatment |
|
Primary |
urobilinogen in urine |
urobilinogen in urine measured in urinalysis as mg/dL |
4 weeks of assigned treatment |
|
Primary |
Heart Rate |
Heart Rate measured using an automated blood pressure machine |
baseline |
|
Primary |
Heart Rate |
Heart rate measured using an automated blood pressure machine |
2 weeks of assigned treatment |
|
Primary |
Heart Rate |
Heart rate measured using an automated blood pressure machine |
4 weeks of assigned treatment |
|
Primary |
Blood Pressure |
Systolic and Diastolic blood pressure measured using an automated blood pressure machine |
baseline |
|
Primary |
Blood Pressure |
Systolic and Diastolic blood pressure measured using an automated blood pressure machine |
2 weeks of assigned treatment |
|
Primary |
Blood Pressure |
Systolic and Diastolic blood pressure measured using an automated blood pressure machine |
4 weeks of assigned treatment |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
Daily food diary |
A list of all food and drink consumed that day |
3 days before baseline visit |
|
Primary |
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 |
|
Primary |
Daily food diary |
A list of all food and drink consumed that day |
2 days before baseline visit |
|
Primary |
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 |
|
Primary |
Daily food diary |
A list of all food and drink consumed that day |
1 day before baseline visit |
|
Primary |
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 |
|
Primary |
Daily food diary |
A list of all food and drink consumed that day |
3 days before 2 week visit |
|
Primary |
Daily food diary |
A list of all food and drink consumed that day |
2 days before 2 week visit |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
Daily food diary |
A list of all food and drink consumed that day |
1 day before 2 week visit |
|
Primary |
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 |
|
Primary |
Daily food diary |
A list of all food and drink consumed that day |
3 days before 4 week visit |
|
Primary |
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 |
|
Primary |
Daily food diary |
A list of all food and drink consumed that day |
2 days before 4 week visit |
|
Primary |
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 |
|
Primary |
Daily food diary |
A list of all food and drink consumed that day |
1 day before 4 week visit |
|