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A Study to Assess Human Pharmacokinetics of a Medical Food Containing Tri-betahydroxybutyrin

NCT07158645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-09-08

No results posted yet for this 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.

Conditions

  • Healthy Volunteer

Interventions

OTHER

Medical Food Tri-betahydroxybutyrin

Medical Food Containing Tri-betahydroxybutyrin

Sponsors & Collaborators

  • NeuroEnergy Ventures, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-20
Primary Completion
2017-11-22
Completion
2017-11-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07158645 on ClinicalTrials.gov