Whole Blood NAD+ Level Change Over Baseline After Supplementation
| Group | Value (MicroMolar) | Spread |
|---|---|---|
| RiaGev | 1.23 | 3.39 |
| Comparator | 0.13 | 4.83 |
Trial · Interventional
Status unknownNot applicableResults postedRegistry dataThis trial does not test a peptide that PepBank tracks.
United States
1 trial · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This current randomized, double-blind, comparator-controlled, cross over study investigates the efficacy and safety of RiaGev™ via evaluation of NAD+, ATP, glucose, insulin, glutathione, and cortisol levels in healthy adults of ages 36-65.
Experimental
RiaGev
RiaGev, 2000mg, BID
Active comparator
Comparator
Comparator matched to RiaGev, BID
Outcomes the sponsor listed as primary.
Whole Blood NAD+ Level Change Over Baseline After Supplementation
Time frame · Day 1 to Day 8
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.
Whole Blood NADP+ Level Change Over Baseline After Supplementation
Time frame · Day 1 to Day 8
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.
Whole Blood NAD+ Plus NADP+ Level Change Over Baseline
Time frame · Day 1 to 8
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.
Serum Glucose Change After RiaGev Supplementation Assessed by OGTT
Time frame · 7 days
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.
Serum Insulin Change After RiaGev Supplementation Assessed by OGTT
Time frame · 7 days
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.
Serum Glutathione (GSH + GSSG) Change Over Baseline After RiaGev Supplementation
Time frame · 7 days
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.
Serum High Energy Phosphate (ATP + ADP) Concentration After RiaGev Supplementation
Time frame · 7 days
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.
The Waking Salivary Cortisol Level After RiaGev Supplementation
Time frame · 7 days
The 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.
The Change in Checklist Individual Strength (CIS) Questionnaire Outcome After a 7-day Supplementation With Either RiaGev™ or Comparator.
Time frame · 7 days
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (MicroMolar) | Spread |
|---|---|---|
| RiaGev | 1.23 | 3.39 |
| Comparator | 0.13 | 4.83 |
| Group | Value (microMolar) | Spread |
|---|---|---|
| RiaGev | 1.30 | 1.72 |
| Comparator | 0.85 | 2.49 |
| Group | Value (microMolar) | Spread |
|---|---|---|
| RiaGev | 2.54 | 4.60 |
| Comparator | 0.97 | 7.10 |
| Group | Value ((mg/dL)*min) | Spread |
|---|---|---|
| RiaGev | 17700.42 | 2525.30 |
| Comparator | 876.25 | 1601.18 |
| Group | Value ((microUnit/mL)*min) | Spread |
|---|---|---|
| RiaGev | 4807.42 | 2419.04 |
| Comparator | 4545.67 | 1915.67 |
| Group | Value (microMolar) | Spread |
|---|---|---|
| RiaGev | 61.85 | 124.73 |
| Comparator | 32.43 | 130.37 |
| Group | Value (microMolar) | Spread |
|---|---|---|
| RiaGev | 327.10 | 42.87 |
| Comparator | 324.94 | 58.55 |
| Group | Value (mcg/dL) | Spread |
|---|---|---|
| RiaGev | 0.43 | 0.15 |
| Comparator | 0.51 | 0.24 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| RiaGevRiaGev, 2000mg, BID RiaGev: Dietary supplementation | 0 / 18 | 0 / 18 | 1 / 18 |
| ComparatorComparator matched to RiaGev, BID Comparator: Dietary ingredient | 0 / 17 | 0 / 17 | 1 / 17 |
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Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
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