Trial · NCT07880925
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the effect of TP daily supplementation on NAD metabolism, as measured by NAD+ concentrations in blood compared to placebo | Baseline (Day 1 pre-dose [-60 min]) and Week 4 (Day 29 ±2 days, pre-dose) | Circulating NAD+ levels in whole blood via liquid LC-MS |
| Secondary | To determine the bioavailability and PK of single dose TP among different doses of TP and compared to a comparator and placebo | Over 24 hours following a single dose on Day 1 (pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose) | PK parameter for plasma trigonelline: AUC0-24 |
| Secondary | To determine the bioavailability and PK of single dose TP among different doses of TP and compared to a comparator and placebo | Over 24 hours following a single dose on Day 1 (pre-dose through 24 hours post-dose) | PK parameter for plasma trigonelline: Cmax |
| Secondary | To determine the bioavailability and PK of single dose TP among different doses of TP and compared to a comparator and placebo | Over 24 hours following a single dose on Day 1 (pre-dose through 24 hours post-dose) | PK parameter for plasma trigonelline: Tmax |
| Secondary | To determine the bioavailability and PK of single dose TP among different doses of TP and compared to a comparator and placebo | Over 24 hours following a single dose on Day 1 (pre-dose through 24 hours post-dose) | PK parameter for plasma trigonelline: T½ |
| Secondary | To determine the bioavailability and PK of single dose TP among different doses of TP and compared to a comparator and placebo | Over 24 hours following a single dose on Day 1 (pre-dose through 24 hours post-dose) | PK parameter for plasma trigonelline: AUCinf |
| Secondary | To determine the bioavailability and PK of single dose TP among different doses of TP and compared to a comparator and placebo | Over 24 hours following a single dose on Day 1 (pre-dose through 24 hours post-dose) | PK parameter for plasma trigonelline: AUC0-24:AUCinf |
| Secondary | To determine the potential accumulation of TP in plasma among different doses of TP and compared to a comparator and placebo after multiple-day dosing | Baseline (Day 1 pre-dose) and Week 4 (within 24 ±60 hours of the last dose) | Change in trough plasma trigonelline concentration |
| Secondary | To evaluate the pharmacodynamic effects of the TP on NAD metabolism over time compared to a comparator and placebo | Baseline (Day 1 pre-dose) and 4 hours post-first dose | Change in whole blood NAD-related metabolites measured via LC-MS |
| Secondary | To evaluate the pharmacodynamic effects of the TP on NAD metabolism over time compared to a comparator and placebo | Baseline (Day 1 pre-dose) and 8 hours post-first dose | Change in whole blood NAD-related metabolites measured via LC-MS |
| Secondary | To evaluate the pharmacodynamic effects of the TP on NAD metabolism over time compared to a comparator and placebo | Baseline (Day 1 pre-dose) and 24 hours post-first dose (Day 2) | Change in whole blood NAD-related metabolites measured via LC-MS |
| Secondary | To evaluate the pharmacodynamic effects of the TP on NAD metabolism over time compared to a comparator and placebo | Baseline (Day 1 pre-dose) and Week 4 (Day 29 ±2 days, pre-dose) | Change in whole blood NAD-related metabolites measured via LC-MS |
| Secondary | To assess the effects of TP on 24-hour urinary excretion of trigonelline and NAD-related metabolites compared to a comparator and placebo | Over 24 hours following acute dosing on Day 1 and over 24 hours following the final dose at Week 4 | 24-hour urinary excretion of trigonelline and NAD-related metabolites |
| Other | To evaluate the pharmacodynamic effects of the TP on NAD metabolism over time compared to a comparator and placebo | Baseline (Day 1 pre-dose [-60 min]) and Week 4 (Day 29 ±2 days, pre-dose) | Change in plasma NAD-related metabolite levels (e.g., NAD⁺, NADH, and related metabolites) measured via LC-MS |
| Other | To assess the effects of TP on systemic inflammatory biomarkers compared to a comparator and placebo | Baseline (Day 1 pre-dose [-60 min]) and Week 4 (Day 29 ±2 days, pre-dose) | Change in circulating inflammatory biomarkers, including hs-CRP, IL-6, TNF-α, and IL-1β |
| Other | To assess the dose-dependent effects of TP at each dose level on systemic NAD metabolism | Baseline (Day 1 pre-dose) and Week 4 (Day 29 ±2 days, pre-dose) | Dose-dependent change in whole blood NAD-related metabolite levels (e.g., NAD⁺, NADH, and related metabolites) |
| Other | To assess the effect of TP daily supplementation on NAD-related metabolite levels in circulating PBMCs compared to a comparator and placebo | Baseline (Day 1 pre-dose [-60 min]) and Week 4 (Day 29 ±2 days, pre-dose) | Change in circulating NAD-related metabolite levels (e.g., NAD⁺, NADH, and related metabolites) in PBMCs |
| Other | To collect vital signs to assess safety and tolerability of TP | Baseline through Week 4 (Day 29 ±2 days) | Assess HR (bpm) for safety and tolerability of TP |
| Other | To collect vital signs to assess safety and tolerability of TP | Baseline through Week 4 (Day 29 ±2 days) | Assess BP (mmHg) for safety and tolerability of TP |
| Other | To take anthropometric measurements to assess the safety and tolerability of TP | Baseline through Week 4 (Day 29 ±2 days) | To assess weight (kg) for safety and tolerability of TP |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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