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NCT07158645 · ClinicalTrials.gov registry record · NA
A Study to Assess Human Pharmacokinetics of a Medical Food Containing Tri-betahydroxybutyrin
A NA study, sponsored by NeuroEnergy Ventures.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT07158645: Completed NA study, sponsored by NeuroEnergy Ventures.
NCT07158645 is a NA study that has completed, run by NeuroEnergy Ventures. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07158645, a NA study, has completed, sponsored by NeuroEnergy Ventures.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study Summary
The objective of this clinical trial is to obtain PK information following the acute intake of a medical food containing tri-betahydroxybutyrin (3BHB) in 18 healthy male subjects. Blood samples will be obtained for the PK analysis of beta-hydroxybutyrate and acetoacetate at t = 1 and 2 h ± 5 min, where t = 0 h is the start of study product consumption. Subjects will be administered a standard breakfast immediately following the t = 2 h blood draw. Subjects will consume the breakfast meal within 30 min and will be instructed to eat until comfortably full. Blood samples will be obtained via the indwelling venous catheter or venipuncture at t = 3, 4, 6, 8, and 12 h ± 5 min, where t = 0 h is the start of study product consumption, for the PK analysis of beta-hydroxybutyrate and acetoacetate. Subjects will be administered a standard snack (immediately following the t = 4 h blood draw), a standard lunch (immediately following the t = 6 h blood draw) and a standard dinner (at t = 10 h) Subjects will consume the meals/snack within 30 min and will be instructed to eat until comfortably full. Following the final blood draw of Visit 2 (day 0) at t = 12 h ± 5 min, the catheter will be removed, AEs will be assessed and a standard snack will be administered for consumption prior to discharge from the clinic. At Visit 3 (day 1), subjects will return to the clinic for clinic visit procedures (i.e., vital signs; review inclusion and exclusion criteria for relevant changes, and concomitant medication/supplement use review). AEs will be assessed and subjects will be queried about study instructions compliance. Blood samples will be obtained at t = 24 h ± 5 min (with backups) by venipuncture for the PK analysis of beta-hydroxybutyrate and acetoacetate, where t = 0 h is the time of study product consumption.
Primary Outcome
Area under the curve (AUC) from pre-product consumption (t = -0.25 h) to 24 h (AUC-0.25-24h)
Interventions
- OTHER Medical Food Tri-betahydroxybutyrin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2017-07-20 |
| Est. Completion | 2017-11-22 |
| Phase | NA |
What the finished NCT07158645 record still lists
NCT07158645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Medical Food Tri-betahydroxybutyrin is the first listed.
NCT07158645 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07158645 about?
NCT07158645 is a clinical study titled "A Study to Assess Human Pharmacokinetics of a Medical Food Containing Tri-betahydroxybutyrin". The objective of this clinical trial is to obtain PK information following the acute intake of a medical food containing tri-betahydroxybutyrin (3BHB) in 18 healthy male subjects. Blood samples will be obtained for the PK analysis of beta-hydroxybutyrate and acetoacetate at t = 1 and 2 h ± 5 min, wh...
What is the current status of trial NCT07158645?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2017-07-20. Estimated completion is 2017-11-22.
What interventions are being tested in trial NCT07158645?
The interventions under investigation include: Medical Food Tri-betahydroxybutyrin (OTHER).
Who is sponsoring clinical trial NCT07158645?
This trial is sponsored by NeuroEnergy Ventures, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07158645's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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