NCT07289165

Comparison of Pharmacokinetic Responses to Three Ketone Esters

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: NeuroEnergy Ventures, Inc. · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine how the body absorbs, digests, and metabolizes three different investigational ketone dietary supplements (ketone monoester, ketone tri-ester, ketone salt) and to assess gastrointestinal tolerance or other adverse effects. This study is considered investigational because data are being collected on the differences over time between three active study products. Consumption of these study products are not intended to diagnose, treat, cure, or prevent any disease.

Detailed description

* This study is a randomized, double-blind, crossover trial of N=18 apparently healthy men and women between 30 and 70 years old to be recruited at a single investigational center. * Participants will attend 7 study visits. During Visit 1 participants will be screened for eligibility \[i.e., medical history, routine blood work, background baseline diet\]. During visits 2, 4, and 6 participants will undergo consumption of a study product (either ketone monester, ketone triester, or ketone salt) and serial blood draws for serum beta-hydroxybutyrate (BHB) will be used to assess the pharmacokinetic (PK) response over an 8-hour period with an additional 24-hour post-ingestion blood draw (to occur on visits 3, 5 and 7). In addition, participants will rate their overall GI tolerance, alertness, and focus via visual analog scales (VAS). During visits 3, 5 and 7 (which will be 24 hours after visits 2, 4, and 6, respectively) participants will undergo a single blood draw for BHB at the 24-hour post ingestion time point and rate their overall GI tolerance via VAS. * Comprehensive side effect profile/ adverse event monitoring will take place throughout the study duration. The study will be conducted following ICH-GCP guidelines to ensure subject safety and scientific integrity of the data.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary Supplement containing Tri-betahydroxybutyrin	Ketone Tri Ester
DIETARY_SUPPLEMENT	Dietary Supplement containing a ketone mono Ester	Ketone Mono Ester
DIETARY_SUPPLEMENT	Dietary supplement containing a ketone salt	Dietary Supplement from a ketone salt

Timeline

• Start date: 2025-07-15
• Primary completion: 2025-12-01
• Completion: 2026-02-01
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States