Trial Outcomes & Findings for Assessment of BHB Concentration Agreement Among Sampling Locations and the Impact of Ketosis on EPO, and More (NCT NCT06053138)
NCT ID: NCT06053138
Last Updated: 2026-04-28
Results Overview
Venous plasma beta-hydroxybutyrate (BHB) concentration measured in mmol/L. The outcome represents the change from baseline (0 minutes) to the maximum observed BHB concentration during the acute ketosis exposure.
COMPLETED
NA
16 participants
Baseline (0 minutes) to peak concentration during acute ketosis exposure (0-180 minutes)
2026-04-28
Participant Flow
Particpants recruited through notice boards as per protocol
All participants underwent an acute ketone ester exposure prior to randomisation to either the Ketosis or Placebo arm
Participant milestones
| Measure |
Ketosis
Participants randomized to receive intermittent ketone ester during the randomized treatment phase.
|
Placebo
Participants randomized to receive placebo during the randomized treatment phase.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
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 |
Ketosis
n=8 Participants
Ketosis (the condition being investigated) is obtained by ingestion of a ketone monoester
|
Control
n=8 Participants
The control arm is a drink matched in taste, volume, appearence, and viscosity to that of the active/experimental arm
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 9.1 • n=8 Participants
|
44.2 years
STANDARD_DEVIATION 8.6 • n=8 Participants
|
42 years
STANDARD_DEVIATION 8.7 • n=16 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
9 Participants
n=16 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Erythropoietin
|
9.0 IU/L
STANDARD_DEVIATION 2.8 • n=8 Participants
|
8.8 IU/L
STANDARD_DEVIATION 4.8 • n=8 Participants
|
8.9 IU/L
STANDARD_DEVIATION 3.8 • n=16 Participants
|
|
Beta-hydroxybutyrate
|
0.04 mmol/L
STANDARD_DEVIATION 0.02 • n=8 Participants
|
0.06 mmol/L
STANDARD_DEVIATION 0.04 • n=8 Participants
|
0.05 mmol/L
STANDARD_DEVIATION 0.03 • n=16 Participants
|
PRIMARY outcome
Timeframe: Baseline (0 minutes) to peak concentration during acute ketosis exposure (0-180 minutes)Population: All participants (N=16) underwent the acute ketosis exposure prior to randomization. The outcome represents peak BHB concentration minus baseline concentration.
Venous plasma beta-hydroxybutyrate (BHB) concentration measured in mmol/L. The outcome represents the change from baseline (0 minutes) to the maximum observed BHB concentration during the acute ketosis exposure.
Outcome measures
| Measure |
BHB Ketone Monoester Drink
n=8 Participants
Participants received a BHB ketone monoester drink at baseline and again at 60 minutes during the acute ketosis exposure.
|
Placebo Drink Matched in Taste, Volume, and Viscosity
n=8 Participants
Placebo drink based on recipe from BHB ketone monoester drink (KE4, KetoneAid) matched in volume, taste and viscosity
|
|---|---|---|
|
Change in Venous Plasma Beta-hydroxybutyrate (BHB) From Baseline to Peak During Acute Ketosis Exposure
|
3.5 mmol/l
Interval 3.3 to 3.8
|
0.04 mmol/l
Interval 0.03 to 0.05
|
PRIMARY outcome
Timeframe: Day 15 (end of randomized treatment)Population: Participants who completed randomized treatment (N=8 per arm).
Serum erythropoietin (EPO) concentration measured in IU/L. Values represent the mean concentration at the end of randomized treatment.
Outcome measures
| Measure |
BHB Ketone Monoester Drink
n=8 Participants
Participants received a BHB ketone monoester drink at baseline and again at 60 minutes during the acute ketosis exposure.
|
Placebo Drink Matched in Taste, Volume, and Viscosity
n=8 Participants
Placebo drink based on recipe from BHB ketone monoester drink (KE4, KetoneAid) matched in volume, taste and viscosity
|
|---|---|---|
|
Serum Erythropoietin Concentration at Day 15
|
10.3 IU/L
Interval 7.7 to 12.8
|
8.2 IU/L
Interval 6.1 to 10.3
|
PRIMARY outcome
Timeframe: Day 15 (end of randomized treatment)Population: Participants who completed randomized treatment (N=8 per arm).
Plasma estradiol measured in pmol/L at Day 15. Values represent the mean concentration at the end of randomized treatment.
Outcome measures
| Measure |
BHB Ketone Monoester Drink
n=8 Participants
Participants received a BHB ketone monoester drink at baseline and again at 60 minutes during the acute ketosis exposure.
|
Placebo Drink Matched in Taste, Volume, and Viscosity
n=8 Participants
Placebo drink based on recipe from BHB ketone monoester drink (KE4, KetoneAid) matched in volume, taste and viscosity
|
|---|---|---|
|
Estradiol Concentration at Day 15
|
253 pmol/L
Interval -102.0 to 608.0
|
331 pmol/L
Interval -100.0 to 764.0
|
SECONDARY outcome
Timeframe: Day 15 (end of randomized treatment)Population: Participants who completed randomized treatment (N=8 per arm).
Serum ferritin concentration measured in µg/L at Day 15. Values represent the mean concentration at the end of randomized treatment.
Outcome measures
| Measure |
BHB Ketone Monoester Drink
n=8 Participants
Participants received a BHB ketone monoester drink at baseline and again at 60 minutes during the acute ketosis exposure.
|
Placebo Drink Matched in Taste, Volume, and Viscosity
n=8 Participants
Placebo drink based on recipe from BHB ketone monoester drink (KE4, KetoneAid) matched in volume, taste and viscosity
|
|---|---|---|
|
Serum Ferritin Concentration at Day 15
|
72 µg/L
Interval 42.0 to 102.0
|
57 µg/L
Interval 32.0 to 83.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 15 (end of randomized treatment)Population: Participants who completed randomized treatment (N=8 per arm).
Testosterone concentration measured in nmol/L at Day 15. Values represent the mean concentration at the end of randomized treatment.
Outcome measures
| Measure |
BHB Ketone Monoester Drink
n=8 Participants
Participants received a BHB ketone monoester drink at baseline and again at 60 minutes during the acute ketosis exposure.
|
Placebo Drink Matched in Taste, Volume, and Viscosity
n=8 Participants
Placebo drink based on recipe from BHB ketone monoester drink (KE4, KetoneAid) matched in volume, taste and viscosity
|
|---|---|---|
|
Plasma Testosterone Concentration at Day 15
|
9.9 mmol/L
Interval 6.8 to 13.0
|
12.0 mmol/L
Interval 7.9 to 16.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 15 (end of randomized treatment)Population: Participants who completed randomized treatment (N=8 per arm).
Hematocrit, expressed as erythrocyte volume fraction (EVF), measured percent (%). Values represent the mean concentration at the end of randomized treatment.
Outcome measures
| Measure |
BHB Ketone Monoester Drink
n=8 Participants
Participants received a BHB ketone monoester drink at baseline and again at 60 minutes during the acute ketosis exposure.
|
Placebo Drink Matched in Taste, Volume, and Viscosity
n=8 Participants
Placebo drink based on recipe from BHB ketone monoester drink (KE4, KetoneAid) matched in volume, taste and viscosity
|
|---|---|---|
|
Hematocrit at Day 15
|
41 % of full blood
Interval 40.0 to 43.0
|
40 % of full blood
Interval 39.0 to 42.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 15 (end of randomized treatment)Population: Participants who completed randomized treatment (N=8 per arm).
Hemoglobin concentration measured in mmol/L at Day 15. Values represent the mean concentration at the end of randomized treatment.
Outcome measures
| Measure |
BHB Ketone Monoester Drink
n=8 Participants
Participants received a BHB ketone monoester drink at baseline and again at 60 minutes during the acute ketosis exposure.
|
Placebo Drink Matched in Taste, Volume, and Viscosity
n=8 Participants
Placebo drink based on recipe from BHB ketone monoester drink (KE4, KetoneAid) matched in volume, taste and viscosity
|
|---|---|---|
|
Hemoglobin Concentration at Day 15
|
8.6 mmol/L
Interval 8.2 to 9.0
|
8.8 mmol/L
Interval 8.4 to 9.2
|
Adverse Events
Ketosis
Control
Acute Ketone Ester Exposure (Pre-Randomization)
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