Trial Outcomes & Findings for The Safety and Efficacy Study of RiaGev in Healthy Adults (NCT NCT04483011)
NCT ID: NCT04483011
Last Updated: 2020-11-25
Results Overview
Whole blood NAD+ concentration are measured at Day 1, Day 3, Day 5, and Day 8. A NAD+ Level change over baseline (Day 1) is calculated by subtracting the NAD+ level at Day 1 ( e.g Day 5 over Day 1 = Day 5 - Day 1). The significance of change (p value) is calculated comparing within RiaGev or Comparator group, and between RiaGev and Comparator groups.
UNKNOWN
NA
18 participants
Day 1 to Day 8
2020-11-25
Participant Flow
Total of 42 subject screened, 18 enrolled into study and randomized into two groups with 9 subjects each.
Participant milestones
| Measure |
RiaGev, Then Comparator
RiaGev, 2000mg, BID, in Intervention Period 1, then 7 day washout, then cross-over to Comparator in Intervention Period 2
|
Comparator, Then RiaGev
Comparator, BID, in Intervention Period 1, then 7 day washout, then cross-over to RiaGev 2000mg BID in Intervention Period 2
|
|---|---|---|
|
Intervention Period 1 (8 Days)
STARTED
|
9
|
9
|
|
Intervention Period 1 (8 Days)
COMPLETED
|
9
|
9
|
|
Intervention Period 1 (8 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (7 Days)
STARTED
|
9
|
9
|
|
Washout (7 Days)
COMPLETED
|
9
|
8
|
|
Washout (7 Days)
NOT COMPLETED
|
0
|
1
|
|
Intervention Period 2 (8 Days)
STARTED
|
9
|
8
|
|
Intervention Period 2 (8 Days)
COMPLETED
|
9
|
8
|
|
Intervention Period 2 (8 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
RiaGev, Then Comparator
RiaGev, 2000mg, BID, in Intervention Period 1, then 7 day washout, then cross-over to Comparator in Intervention Period 2
|
Comparator, Then RiaGev
Comparator, BID, in Intervention Period 1, then 7 day washout, then cross-over to RiaGev 2000mg BID in Intervention Period 2
|
|---|---|---|
|
Washout (7 Days)
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
The Safety and Efficacy Study of RiaGev in Healthy Adults
Baseline characteristics by cohort
| Measure |
RiaGev, Then Comarator
n=9 Participants
RiaGev, 2000mg, BID, in Period 1, then cross-over to Comparator in Period 2, after 7-day washout.
|
Comparator, Then RiaGev
n=9 Participants
Comparator, BID, in Period 1, then cross-over to RiaGev 2000mg, BID, in Period 2 after 7-day washout.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
50.11 Years
STANDARD_DEVIATION 8.62 • n=5 Participants
|
53.33 Years
STANDARD_DEVIATION 7.31 • n=7 Participants
|
51.72 Years
STANDARD_DEVIATION 7.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Weight
|
75.15 Kg
STANDARD_DEVIATION 14.60 • n=5 Participants
|
79.06 Kg
STANDARD_DEVIATION 19.99 • n=7 Participants
|
77.11 Kg
STANDARD_DEVIATION 17.30 • n=5 Participants
|
|
Height
|
175.22 CM
STANDARD_DEVIATION 8.12 • n=5 Participants
|
172.67 CM
STANDARD_DEVIATION 14.18 • n=7 Participants
|
173.95 CM
STANDARD_DEVIATION 11.09 • n=5 Participants
|
|
BMI
|
24.29 Kg/cm^2
STANDARD_DEVIATION 2.96 • n=5 Participants
|
26.12 Kg/cm^2
STANDARD_DEVIATION 2.75 • n=7 Participants
|
25.21 Kg/cm^2
STANDARD_DEVIATION 2.86 • n=5 Participants
|
|
Systolic Blood Pressure
|
124.57 mmHg
STANDARD_DEVIATION 13.01 • n=5 Participants
|
124.26 mmHg
STANDARD_DEVIATION 9.32 • n=7 Participants
|
124.42 mmHg
STANDARD_DEVIATION 11.16 • n=5 Participants
|
|
Diastolic Blood Pressure
|
78.33 mmHg
STANDARD_DEVIATION 7.63 • n=5 Participants
|
78.31 mmHg
STANDARD_DEVIATION 5.01 • n=7 Participants
|
78.32 mmHg
STANDARD_DEVIATION 6.32 • n=5 Participants
|
|
Heart Rate
|
64.11 bpm
STANDARD_DEVIATION 19.62 • n=5 Participants
|
66.33 bpm
STANDARD_DEVIATION 9.11 • n=7 Participants
|
65.22 bpm
STANDARD_DEVIATION 14.35 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Population: ITT
Whole blood NAD+ concentration are measured at Day 1, Day 3, Day 5, and Day 8. A NAD+ Level change over baseline (Day 1) is calculated by subtracting the NAD+ level at Day 1 ( e.g Day 5 over Day 1 = Day 5 - Day 1). The significance of change (p value) is calculated comparing within RiaGev or Comparator group, and between RiaGev and Comparator groups.
Outcome measures
| Measure |
RiaGev
n=18 Participants
RiaGev, 2000mg, BID
RiaGev: Dietary supplementation
|
Comparator
n=17 Participants
Comparator matched to RiaGev, BID
Comparator: Dietary ingredients
|
|---|---|---|
|
Whole Blood NAD+ Level Change Over Baseline After Supplementation
Day 3 over Day 1
|
1.23 MicroMolar
Standard Deviation 3.39
|
0.13 MicroMolar
Standard Deviation 4.83
|
|
Whole Blood NAD+ Level Change Over Baseline After Supplementation
Day 5 over Day 1
|
2.12 MicroMolar
Standard Deviation 4.72
|
-0.20 MicroMolar
Standard Deviation 2.79
|
|
Whole Blood NAD+ Level Change Over Baseline After Supplementation
Day 8 over Day 1
|
1.30 MicroMolar
Standard Deviation 3.20
|
-0.60 MicroMolar
Standard Deviation 2.53
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Population: ITT
Whole blood NADP+ concentration are measured at Day 1, Day 3, Day 5, and Day 8. NADP+ level changes over baseline (Day 1) are calculated by substracting NADP+ level at Day 1. The significance of change (p values) are calculated comparing changes within and between RiaGev and Comparator groups.
Outcome measures
| Measure |
RiaGev
n=18 Participants
RiaGev, 2000mg, BID
RiaGev: Dietary supplementation
|
Comparator
n=17 Participants
Comparator matched to RiaGev, BID
Comparator: Dietary ingredients
|
|---|---|---|
|
Whole Blood NADP+ Level Change Over Baseline After Supplementation
Day 3 over Day 1
|
1.30 microMolar
Standard Deviation 1.72
|
0.85 microMolar
Standard Deviation 2.49
|
|
Whole Blood NADP+ Level Change Over Baseline After Supplementation
Day 5 over Day 1
|
1.88 microMolar
Standard Deviation 2.55
|
0.51 microMolar
Standard Deviation 1.52
|
|
Whole Blood NADP+ Level Change Over Baseline After Supplementation
Day 8 over Day 1
|
1.33 microMolar
Standard Deviation 1.88
|
0.34 microMolar
Standard Deviation 1.34
|
PRIMARY outcome
Timeframe: Day 1 to 8Population: ITT population
The change in whole blood NAD+ plus NADP+ levels from Day 1 baseline to Day 8 when supplemented with RiaGev™ or comparator. The parameter is measured at Day 1, Day 3, Day 5, and Day 8. A change over baseline is calculated by subtracting Day 1 value. The significance of changes (p value) are calculated by comparing within and between RiaGev and Comparator groups.
Outcome measures
| Measure |
RiaGev
n=18 Participants
RiaGev, 2000mg, BID
RiaGev: Dietary supplementation
|
Comparator
n=17 Participants
Comparator matched to RiaGev, BID
Comparator: Dietary ingredients
|
|---|---|---|
|
Whole Blood NAD+ Plus NADP+ Level Change Over Baseline
Day 3 over Day 1
|
2.54 microMolar
Standard Deviation 4.60
|
0.97 microMolar
Standard Deviation 7.10
|
|
Whole Blood NAD+ Plus NADP+ Level Change Over Baseline
Day 5 over Day 1
|
4.01 microMolar
Standard Deviation 6.57
|
0.40 microMolar
Standard Deviation 3.88
|
|
Whole Blood NAD+ Plus NADP+ Level Change Over Baseline
Day 8 over Day 1
|
2.63 microMolar
Standard Deviation 4.30
|
-0.24 microMolar
Standard Deviation 3.39
|
SECONDARY outcome
Timeframe: 7 daysPopulation: ITT population
The serum glucose as assessed by a standard Oral Glucose Tolerance Test (OGTT) on Day 1 and on Day 8 after 7-day supplementation with either RiaGev™ or comparator. Incremental Area Under the Curve (iAUC) is used as overall blood glucose. Serum glucose change is calculated by subtracting iAUC on Day 1 from iAUC on Day 8. The significance of change (p value) is calculated by comparing values on Day 8 and Day 1.
Outcome measures
| Measure |
RiaGev
n=18 Participants
RiaGev, 2000mg, BID
RiaGev: Dietary supplementation
|
Comparator
n=17 Participants
Comparator matched to RiaGev, BID
Comparator: Dietary ingredients
|
|---|---|---|
|
Serum Glucose Change After RiaGev Supplementation Assessed by OGTT
Day 1
|
17700.42 (mg/dL)*min
Standard Deviation 2525.30
|
876.25 (mg/dL)*min
Standard Deviation 1601.18
|
|
Serum Glucose Change After RiaGev Supplementation Assessed by OGTT
Day 8
|
662.50 (mg/dL)*min
Standard Deviation 2031.70
|
574.17 (mg/dL)*min
Standard Deviation 1640.77
|
|
Serum Glucose Change After RiaGev Supplementation Assessed by OGTT
Change from Day 1 to Day 8
|
-1037.92 (mg/dL)*min
Standard Deviation 1590.74
|
-302.08 (mg/dL)*min
Standard Deviation 1427.42
|
SECONDARY outcome
Timeframe: 7 daysPopulation: ITT population
Serum insulin is assessed by a standard Oral Glucose Tolerance Test (OGTT) on Day 1 and Day 8 after 7-day supplementation with either RiaGev™ or comparator. Serum insulin change is calculated by substracting its level on Day 1 from Day 8. The significance of change (p value) is calculated by comparing Day 1 and Day 8.
Outcome measures
| Measure |
RiaGev
n=18 Participants
RiaGev, 2000mg, BID
RiaGev: Dietary supplementation
|
Comparator
n=17 Participants
Comparator matched to RiaGev, BID
Comparator: Dietary ingredients
|
|---|---|---|
|
Serum Insulin Change After RiaGev Supplementation Assessed by OGTT
Day 1
|
4807.42 (microUnit/mL)*min
Standard Deviation 2419.04
|
4545.67 (microUnit/mL)*min
Standard Deviation 1915.67
|
|
Serum Insulin Change After RiaGev Supplementation Assessed by OGTT
Day 8
|
4672.29 (microUnit/mL)*min
Standard Deviation 2427.27
|
4410.88 (microUnit/mL)*min
Standard Deviation 1929.12
|
|
Serum Insulin Change After RiaGev Supplementation Assessed by OGTT
Change from Day 1 to Day 8
|
-135.13 (microUnit/mL)*min
Standard Deviation 2153.66
|
-134.79 (microUnit/mL)*min
Standard Deviation 1830.16
|
SECONDARY outcome
Timeframe: 7 daysPopulation: ITT
Total serum Glutathione (GSH + GSSG) is measured on Day 1, Day 3, Day 5 and Day 8. after a 7-day supplementation with either RiaGev™ or comparator. A change over baseline is calculated by subtracting glutathione level on Day 1 baseline (e g Day 5 over Day 1 = Day 5 - Day 1). The significance of change (p value) is calculated within the RiaGev or Comparator group.
Outcome measures
| Measure |
RiaGev
n=18 Participants
RiaGev, 2000mg, BID
RiaGev: Dietary supplementation
|
Comparator
n=17 Participants
Comparator matched to RiaGev, BID
Comparator: Dietary ingredients
|
|---|---|---|
|
Serum Glutathione (GSH + GSSG) Change Over Baseline After RiaGev Supplementation
Day 5 over Day 1
|
70.20 microMolar
Standard Deviation 123.89
|
15.55 microMolar
Standard Deviation 88.62
|
|
Serum Glutathione (GSH + GSSG) Change Over Baseline After RiaGev Supplementation
Day 8 over Day 1
|
9.55 microMolar
Standard Deviation 66.82
|
-15.08 microMolar
Standard Deviation 76.05
|
|
Serum Glutathione (GSH + GSSG) Change Over Baseline After RiaGev Supplementation
Day 3 over Day 1
|
61.85 microMolar
Standard Deviation 124.73
|
32.43 microMolar
Standard Deviation 130.37
|
SECONDARY outcome
Timeframe: 7 daysPopulation: ITT
Serum high energy phosphate (ATP + ADP) after a 7-day supplementation with either RiaGev™ or comparator. The measurement take place on Day 1, Day 3, Day 5, and Day 8. Comparison are made between the two groups. The significance (p value) is also calculated between the groups.
Outcome measures
| Measure |
RiaGev
n=18 Participants
RiaGev, 2000mg, BID
RiaGev: Dietary supplementation
|
Comparator
n=17 Participants
Comparator matched to RiaGev, BID
Comparator: Dietary ingredients
|
|---|---|---|
|
Serum High Energy Phosphate (ATP + ADP) Concentration After RiaGev Supplementation
Day 1 (baseline)
|
327.10 microMolar
Standard Deviation 42.87
|
324.94 microMolar
Standard Deviation 58.55
|
|
Serum High Energy Phosphate (ATP + ADP) Concentration After RiaGev Supplementation
Day 3
|
351.18 microMolar
Standard Deviation 75.71
|
345.98 microMolar
Standard Deviation 102.56
|
|
Serum High Energy Phosphate (ATP + ADP) Concentration After RiaGev Supplementation
Day 5
|
353.28 microMolar
Standard Deviation 82.03
|
329.27 microMolar
Standard Deviation 94.34
|
|
Serum High Energy Phosphate (ATP + ADP) Concentration After RiaGev Supplementation
Day 8
|
330.40 microMolar
Standard Deviation 41.89
|
326.20 microMolar
Standard Deviation 45.46
|
SECONDARY outcome
Timeframe: 7 daysThe salivary cortisol level after a 7-day supplementation with either RiaGev™ or comparator. The measurement take place on Day 1, 3, 5, and 8. The salivary cortisol level as well as change of salivary cortisol level over baseline (Day 1) are reported. Comparisons are make both between the RiaGev and Comparison groups as well as within RiaGev group against its Day 1 baseline. The corresponding significance (p value) will be calculated.
Outcome measures
| Measure |
RiaGev
n=18 Participants
RiaGev, 2000mg, BID
RiaGev: Dietary supplementation
|
Comparator
n=17 Participants
Comparator matched to RiaGev, BID
Comparator: Dietary ingredients
|
|---|---|---|
|
The Waking Salivary Cortisol Level After RiaGev Supplementation
Day 1 (baseline)
|
0.43 mcg/dL
Standard Deviation 0.15
|
0.51 mcg/dL
Standard Deviation 0.24
|
|
The Waking Salivary Cortisol Level After RiaGev Supplementation
Day 3
|
0.40 mcg/dL
Standard Deviation 0.19
|
0.47 mcg/dL
Standard Deviation 0.19
|
|
The Waking Salivary Cortisol Level After RiaGev Supplementation
Day 5
|
0.41 mcg/dL
Standard Deviation 0.32
|
0.57 mcg/dL
Standard Deviation 0.29
|
|
The Waking Salivary Cortisol Level After RiaGev Supplementation
Day 3 over Day 1
|
-0.03 mcg/dL
Standard Deviation 0.18
|
-0.04 mcg/dL
Standard Deviation 0.26
|
|
The Waking Salivary Cortisol Level After RiaGev Supplementation
Day 8
|
0.38 mcg/dL
Standard Deviation 0.18
|
0.51 mcg/dL
Standard Deviation 0.22
|
|
The Waking Salivary Cortisol Level After RiaGev Supplementation
Day 5 over Day 1
|
-0.02 mcg/dL
Standard Deviation 0.34
|
0.07 mcg/dL
Standard Deviation 0.36
|
|
The Waking Salivary Cortisol Level After RiaGev Supplementation
Day 8 over Day 1
|
-0.05 mcg/dL
Standard Deviation 0.19
|
0.00 mcg/dL
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: 7 daysPopulation: ITT
Checklist Individual Strength (CIS) Questionnaire was designed by the Dutch research team of Vercoulen et el, to measure fatigues. A standard CIS Questionnaire contains 20 questions, each scoring 1 to 7, total score 20 - 140, with higher score indicating more tiredness. Thus, a negative value in changing score (such as Day 5 - Day 1 baseline) means reduction of tiredness and verse versa.
Outcome measures
| Measure |
RiaGev
n=18 Participants
RiaGev, 2000mg, BID
RiaGev: Dietary supplementation
|
Comparator
n=17 Participants
Comparator matched to RiaGev, BID
Comparator: Dietary ingredients
|
|---|---|---|
|
The Change in Checklist Individual Strength (CIS) Questionnaire Outcome After a 7-day Supplementation With Either RiaGev™ or Comparator.
Day 3 over Day 1
|
-9.78 Score on a scale
Standard Deviation 13.45
|
-4.28 Score on a scale
Standard Deviation 5.93
|
|
The Change in Checklist Individual Strength (CIS) Questionnaire Outcome After a 7-day Supplementation With Either RiaGev™ or Comparator.
Day 5 over Day 1
|
-8.33 Score on a scale
Standard Deviation 12.99
|
-2.56 Score on a scale
Standard Deviation 5.66
|
|
The Change in Checklist Individual Strength (CIS) Questionnaire Outcome After a 7-day Supplementation With Either RiaGev™ or Comparator.
Day 8 over Day 1
|
-5.78 Score on a scale
Standard Deviation 16.27
|
-1.67 Score on a scale
Standard Deviation 7.54
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 daysPopulation: ITT Populaiton
The number of out-of-norm incidence (as indicator of safety) will be reported. Clinical chemistry parameters including alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, creatinine, electrolytes (Na, K, Cl), fasting glucose. When a parameter is within normal limit, it will been reported as 0 out-of-norm.
Outcome measures
| Measure |
RiaGev
n=18 Participants
RiaGev, 2000mg, BID
RiaGev: Dietary supplementation
|
Comparator
n=17 Participants
Comparator matched to RiaGev, BID
Comparator: Dietary ingredients
|
|---|---|---|
|
The Number of Out-of-norm Clinical Chemistry Parameters When Supplemented With RiaGev or Comparator
Creatinine
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Clinical Chemistry Parameters When Supplemented With RiaGev or Comparator
Fasting Blood Glucose
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Clinical Chemistry Parameters When Supplemented With RiaGev or Comparator
Aspartate Transaminase (AST)
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Clinical Chemistry Parameters When Supplemented With RiaGev or Comparator
Alanine Transaminase (ALT)
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Clinical Chemistry Parameters When Supplemented With RiaGev or Comparator
Chloride
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Clinical Chemistry Parameters When Supplemented With RiaGev or Comparator
Potassium
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Clinical Chemistry Parameters When Supplemented With RiaGev or Comparator
Sodium
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Clinical Chemistry Parameters When Supplemented With RiaGev or Comparator
Creatine Clearance
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Clinical Chemistry Parameters When Supplemented With RiaGev or Comparator
Bilirubin
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Clinical Chemistry Parameters When Supplemented With RiaGev or Comparator
Hemoglobin A1c
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Clinical Chemistry Parameters When Supplemented With RiaGev or Comparator
Estimated Average Glucose
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 daysPopulation: ITT population
The number of out-of-norm hematology parameter incidence (as indicator of safety) will be reported. Hematology parameters include white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), red blood cell (RBC) count, hemoglobin, hematocrit, platelet count, RBC indices (mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW). When a parameter is within normal limits, it is reported as 0 out-of-norm.
Outcome measures
| Measure |
RiaGev
n=18 Participants
RiaGev, 2000mg, BID
RiaGev: Dietary supplementation
|
Comparator
n=17 Participants
Comparator matched to RiaGev, BID
Comparator: Dietary ingredients
|
|---|---|---|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Instrument Absolute Neotrophil Count (IANC)
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Immature Granulocytes (IGAB)
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Absolute Neutrophil Counts
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
White Blood Cell Counts
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Red Blood Cell Counts
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Hemoglobin
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Hemotocrit
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Mean Corpuscular Volume
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Mean Corpuscular Hemoglobin
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Mean Corpuscular Hemoglobin Concentration
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Red Blood Cell Distribution Width
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Platelet
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Meran Package Volume
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Nucleated Red Blood Cells (NRBCA)
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Absolute Lymphocyte Count
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Absolute Monocyte Count
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Absolute Eosinophil Counts
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Hematology Parameters When Supplemented With RiaGev or Comparator.
Absolute Basophil Count
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 daysPopulation: ITT population
Vital signs include blood pressure (BP) and heart rate (HR). The number of out-of-norm incidence will be reported. When a parameter is within normal limits, it is reported as 0 out-of-norm.
Outcome measures
| Measure |
RiaGev
n=18 Participants
RiaGev, 2000mg, BID
RiaGev: Dietary supplementation
|
Comparator
n=17 Participants
Comparator matched to RiaGev, BID
Comparator: Dietary ingredients
|
|---|---|---|
|
The Number of Out-of-norm Vital Signs When Supplemented With RiaGev or Comparator
Systolic Pressure
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Vital Signs When Supplemented With RiaGev or Comparator
Diastolic Pressure
|
0 Participants
|
0 Participants
|
|
The Number of Out-of-norm Vital Signs When Supplemented With RiaGev or Comparator
Heart Rate
|
0 Participants
|
0 Participants
|
Adverse Events
RiaGev
Comparator
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RiaGev
n=18 participants at risk
RiaGev, 2000mg, BID
RiaGev: Dietary supplementation
|
Comparator
n=17 participants at risk
Comparator matched to RiaGev, BID
Comparator: Dietary ingredient
|
|---|---|---|
|
General disorders
Asthenia
|
5.6%
1/18 • Number of events 1 • 22 days
Total number of post-emergent adverse events that are possibly relevant to the study.
|
0.00%
0/17 • 22 days
Total number of post-emergent adverse events that are possibly relevant to the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
1/18 • Number of events 1 • 22 days
Total number of post-emergent adverse events that are possibly relevant to the study.
|
0.00%
0/17 • 22 days
Total number of post-emergent adverse events that are possibly relevant to the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18 • 22 days
Total number of post-emergent adverse events that are possibly relevant to the study.
|
5.9%
1/17 • Number of events 1 • 22 days
Total number of post-emergent adverse events that are possibly relevant to the study.
|
Additional Information
Alex Xue, Chief Technology Officer
Bioenergy Life Science, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place