Trial Outcomes & Findings for Ketone Pharmacokinetic Study in HFrEF (NCT NCT05757193)

NCT ID: NCT05757193

Last Updated: 2024-12-27

Results Overview

The pH scale ranges from 0 to 14, with 7 being neutral. Each number on the pH scale represents a ten-fold change in the acidity or basicity of a solution.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 20 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2024-12-27

Participant Flow

Participants were recruited within the Duke University Health System.

Participant milestones

Measure	250 mg/kg Ketone Ester Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg. DeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate	500 mg/kg Ketone Ester Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg. DeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ketone Pharmacokinetic Study in HFrEF

Baseline characteristics by cohort

Measure	250 mg/kg Ketone Ester n=10 Participants Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg. DeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate	500 mg/kg Ketone Ester n=10 Participants Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg. DeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate	Total n=20 Participants Total of all reporting groups
Age, Continuous	63.8 years STANDARD_DEVIATION 9.1 • n=5 Participants	65.0 years STANDARD_DEVIATION 9.0 • n=7 Participants	64.4 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

The pH scale ranges from 0 to 14, with 7 being neutral. Each number on the pH scale represents a ten-fold change in the acidity or basicity of a solution.

Outcome measures

Measure	250 mg/kg Ketone Ester n=10 Participants Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg. DeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate	500 mg/kg Ketone Ester n=10 Participants Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg. DeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
Venous pH Measured Via Peripheral Blood	7.30 unitless Standard Deviation 0.04	7.28 unitless Standard Deviation 0.04

PRIMARY outcome

Timeframe: 1 hour

Outcome measures

Measure	250 mg/kg Ketone Ester n=10 Participants Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg. DeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate	500 mg/kg Ketone Ester n=10 Participants Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg. DeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
Glucose Level Measured Via Peripheral Blood	136 mg/dL Standard Deviation 70	101 mg/dL Standard Deviation 45

PRIMARY outcome

Timeframe: 1 hour

Taken by blood pressure cuff on the arm

Outcome measures

Measure	250 mg/kg Ketone Ester n=10 Participants Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg. DeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate	500 mg/kg Ketone Ester n=10 Participants Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg. DeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
Systolic Blood Pressure	108 mmHg Standard Deviation 12	110 mmHg Standard Deviation 15

PRIMARY outcome

Timeframe: 1 hour

BHB is a chemical that is made by the body. It provides energy when not enough carbohydrates or sugars have been eaten.

Outcome measures

Measure	250 mg/kg Ketone Ester n=10 Participants Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg. DeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate	500 mg/kg Ketone Ester n=9 Participants Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg. DeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
Beta-hydroxybutyrate (BHB) Level Measured Via Peripheral Blood	1.88 millimolar Standard Deviation 0.30	2.78 millimolar Standard Deviation 0.54

Adverse Events

250 mg/kg Ketone Ester

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

500 mg/kg Ketone Ester

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	250 mg/kg Ketone Ester n=10 participants at risk Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg. DeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate	500 mg/kg Ketone Ester n=10 participants at risk Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg. DeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
Nervous system disorders Headache	10.0% 1/10 • Reported prior to the end of the study visit, up to 4 hours after ketone ester ingestion.	10.0% 1/10 • Reported prior to the end of the study visit, up to 4 hours after ketone ester ingestion.

Additional Information

Senthil Selvaraj, MD

Duke University

Phone: 919-660-0730

Email: Senthil.Selvaraj@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place