Trial Outcomes & Findings for The Effect of Different Ketone Supplements on β-OHB and Blood Glucose in Healthy Individuals (NCT NCT05273411)
NCT ID: NCT05273411
Last Updated: 2024-08-01
Results Overview
Are under the curve (AUC) across 240 minutes after supplement consumption (assessed at baseline and 15, 30, 60, 90, 120, 180, and 240 post-supplementation)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
Results posted on
2024-08-01
Participant Flow
Participant milestones
| Measure |
Arm 1
1 x 20 mL; (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester; single-dose pharmacokinetic study over 4 hours.
1 x 237 mL; Beta-hydroxybutyric acid; single-dose pharmacokinetic study over 4 hours.
1 x 35 mL; 1,3-Butanediol; single-dose pharmacokinetic study over 4 hours.
|
Arm 2
1 x 20 mL; (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester; single-dose pharmacokinetic study over 4 hours.
1 x 35 mL; 1,3-Butanediol; single-dose pharmacokinetic study over 4 hours.
1 x 237 mL; Beta-hydroxybutyric acid; single-dose pharmacokinetic study over 4 hours.
|
Arm 3
1 x 35 mL; 1,3-Butanediol; single-dose pharmacokinetic study over 4 hours.
1 x 237 mL; Beta-hydroxybutyric acid; single-dose pharmacokinetic study over 4 hours.
1 x 20 mL; (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester; single-dose pharmacokinetic study over 4 hours.
|
Arm 4
1 x 35 mL; 1,3-Butanediol; single-dose pharmacokinetic study over 4 hours.
1 x 20 mL; (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester; single-dose pharmacokinetic study over 4 hours.
1 x 237 mL; Beta-hydroxybutyric acid; single-dose pharmacokinetic study over 4 hours.
|
Arm 5
1 x 237 mL; Beta-hydroxybutyric acid; single-dose pharmacokinetic study over 4 hours.
1 x 35 mL; 1,3-Butanediol; single-dose pharmacokinetic study over 4 hours.
1 x 20 mL; (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester; single-dose pharmacokinetic study over 4 hours.
|
Arm 6
1 x 237 mL; Beta-hydroxybutyric acid; single-dose pharmacokinetic study over 4 hours.
1 x 20 mL; (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester; single-dose pharmacokinetic study over 4 hours.
1 x 35 mL; 1,3-Butanediol; single-dose pharmacokinetic study over 4 hours.
|
|---|---|---|---|---|---|---|
|
Intervention Period 1
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Intervention Period 1
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Intervention Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention Period 2
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Intervention Period 2
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Intervention Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention Period 3
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Intervention Period 3
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Intervention Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=12 Participants
Single-dose pharmacokinetic study over 4 hours, three-way crossover study of three different ketone supplements (see description).
|
|---|---|
|
Age, Continuous
|
29.1 years
STANDARD_DEVIATION 4.9 • n=12 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=12 Participants
|
|
Region of Enrollment
Canada
|
12 participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)Are under the curve (AUC) across 240 minutes after supplement consumption (assessed at baseline and 15, 30, 60, 90, 120, 180, and 240 post-supplementation)
Outcome measures
| Measure |
(R)-3-hydroxybutyl (R)-3-hydroxybutyrate Ketone Monoester
n=12 Participants
1 x 20 mL
(R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester: Single-dose pharmacokinetic study over 4 hours.
|
Beta-hydroxybutyric Acid
n=12 Participants
1 x 237 mL
Beta-hydroxybutyric acid: Beta-hydroxybutyric acid
|
1,3-Butanediol
n=12 Participants
1 x 35 mL
1,3-Butanediol: 1,3-Butanediol
|
|---|---|---|---|
|
Blood Beta-hydroxybutyrate
|
217 area under the curve (mmol/L x 240 min)
Standard Deviation 51
|
192 area under the curve (mmol/L x 240 min)
Standard Deviation 63
|
176 area under the curve (mmol/L x 240 min)
Standard Deviation 59
|
SECONDARY outcome
Timeframe: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)Area under the curve (AUC)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)Change over time
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)Change over time
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 240 minutes post-supplementationQuestionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 240 minutes post-supplementationQuestionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 minutes post-supplementationQuestionnaire
Outcome measures
Outcome data not reported
Adverse Events
(R)-3-hydroxybutyl (R)-3-hydroxybutyrate Ketone Monoester
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Beta-hydroxybutyric Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1,3-Butanediol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place