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.
* 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
18
Ketone Tri Ester
Ketone Mono Ester
Dietary Supplement from a ketone salt
CAHS
Canfield, Ohio, United States
Serum BHB concentration maximum (Cmax)
Time frame: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
time to maximum concentration (Tmax)
Time frame: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
area under the curve (AUC),
Time frame: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
elimination half-life (T1/2),
Time frame: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
oral clearance
Time frame: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
volume of distribution
Time frame: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
Visual Analogue Scale for GI tolerance
Time frame: assessed at 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
Safety (vital signs) and Adverse Events
Time frame: assessed at 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.