Strategies to Augment Ketosis: Optimization of Ketone Delivery Strategies

NAActive, not recruitingINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

June 5, 2023

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2027

Conditions
Ketosis
Interventions
DIETARY_SUPPLEMENT

Ketone Supplement

Four different exogenous ketone products at two serving sizes or a non-ketogenic placebo (one study product per test day). 1) Monoester of BHB (R)-1,3 butanediol (BHB Mono-ester), 2) diester of hexanoic acid (a ketogenic medium chain fatty acid) and (R)-1,3 butanediol (C6 Di-ester) 3) diester of AcAc and (R,S)-1,3 butanediol (AcAc Di-ester) \& 4) (R) -1,3 butanediol only (BDO). All products will be delivered in 2 different dosages 180mg/kg and 360mg/kg on separate testing days.

BEHAVIORAL

Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale

Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale will be administered at beginning and end of testing day to tests palatability of supplement

BIOLOGICAL

Blood Draw

IV cannula will be inserted at the start of each Test Day, and removed at the end of each Test Day, Blood samples will be collected according to the schedule in Figure 1. Cannula will be flushed with a small volume of saline after each sample to maintain patency. We will draw 504 mL of blood, which is about 2.1 cups throughout the 4-week intervention

OTHER

Breath Reading

Participants will breathe into a commercially available handheld breath acetone analyzer according to the schedule. Participants will wear a fitted face mask attached to a metabolic cart for a 10-minute period every 60 minutes

OTHER

Heart Rate Variability

Participants will wear a Bluetooth heart rate monitor chest strap throughout the test day.

OTHER

CGM/CKM

Continuous Ketone Monitor will be applied at the start of Test Day 1. The sensor will be checked by the study team at each test day and will be removed and replaced by a fresh sensor at \~2- week intervals during the study. The sensor will be removed at the end of the final test day

RADIATION

DXA

Lean Body Mass will be assessed once via DXA

OTHER

Urine Analysis

Prior to consumption of the Study Product, participants will be asked to completely void bladder. And hydration status will be determined via urine specific gravity (USG) reporting \<1.025. Urine passed after the ingestion of the study product will be collected in a plastic container; participants will be asked to void their bladder and collect urine at the end of the test day. The volume produced will be recorded at the end of the study and aliquots will be frozen and stored for future analysis

Trial Locations (1)

43210

The Ohio State University, Columbus

All Listed Sponsors
lead

Ohio State University

OTHER