Trial Outcomes & Findings for Ketone Production With Acute Caffeine Intake (NCT NCT02694601)

NCT ID: NCT02694601

Last Updated: 2023-07-27

Results Overview

Plasma acetoacetate (µmol/L) measured over a 4 hour period.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 4 hours
• Results posted on: 2023-07-27

Participant Flow

Participant milestones

Measure	Ketonemia Following Caffeine Intake Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations. Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5 mg/kg of BW)
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ketone Production With Acute Caffeine Intake

Baseline characteristics by cohort

Measure	Ketonemia Following Caffeine Intake n=10 Participants Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations. Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5 mg/kg of BW)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33 years STANDARD_DEVIATION 19 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment Canada	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 hours

Plasma acetoacetate (µmol/L) measured over a 4 hour period.

Outcome measures

Measure	Ketonemia Following Caffeine Intake n=10 Participants Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations. Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5 mg/kg of BW)
Plasma Acetoacetate Concentrations CTL	26.06 µmol/L Standard Error 3.71
Plasma Acetoacetate Concentrations Caffeine low dose	30.99 µmol/L Standard Error 5.97
Plasma Acetoacetate Concentrations Caffeine high dose	32.10 µmol/L Standard Error 8.40

PRIMARY outcome

Timeframe: 4 hours

Plasma beta-hydroxybutyrate (µmol/L) measured over a 4 hour period.

Outcome measures

Measure	Ketonemia Following Caffeine Intake n=10 Participants Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations. Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5 mg/kg of BW)
Plasma Beta-hydroxybutyrate Concentrations CTL	92.69 µmol/L Standard Error 12.41
Plasma Beta-hydroxybutyrate Concentrations Caffeine low dose	127.57 µmol/L Standard Error 16.98
Plasma Beta-hydroxybutyrate Concentrations Caffeine high dose	144.99 µmol/L Standard Error 16.77

SECONDARY outcome

Timeframe: 4 hours

Plasma glucose (mmol/L) measured over a 4 hour period.

Outcome measures

Measure	Ketonemia Following Caffeine Intake n=10 Participants Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations. Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5 mg/kg of BW)
Plasma Glucose Concentrations CTL	4.95 mmol/L Standard Error 0.35
Plasma Glucose Concentrations Caffeine low dose	4.96 mmol/L Standard Error 0.29
Plasma Glucose Concentrations Caffeine high dose	4.98 mmol/L Standard Error 0.25

SECONDARY outcome

Timeframe: 4 hours

Plasma cholesterol (mmol/L) measured over a 4 hour period.

Outcome measures

Measure	Ketonemia Following Caffeine Intake n=10 Participants Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations. Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5 mg/kg of BW)
Plasma Cholesterol Concentrations CTL	4.26 mmol/L Standard Error 0.47
Plasma Cholesterol Concentrations Caffeine low dose	4.76 mmol/L Standard Error 0.35
Plasma Cholesterol Concentrations Caffeine high dose	4.81 mmol/L Standard Error 0.34

SECONDARY outcome

Timeframe: 4 hours

Plasma triglycerides (mmol/L) measured over a 4 hour period.

Outcome measures

Measure	Ketonemia Following Caffeine Intake n=10 Participants Participants have to follow three sequential visits of four hours each, which included a breakfast with one of the doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and repeated blood sampling in order to evaluate ketone concentrations. Intervention 1: Control; no caffeine intake Intervention 2: Caffeine low dose (2.5 mg/kg of BW) Intervention 3: Caffeine high dose (5 mg/kg of BW)
Plasma Triglyceride Concentrations CTL	0.90 mmol/L Standard Error 0.15
Plasma Triglyceride Concentrations Caffeine low dosee	0.92 mmol/L Standard Error 0.15
Plasma Triglyceride Concentrations Caffeine high dosee	0.97 mmol/L Standard Error 0.14

Adverse Events

Ketonemia Following Caffeine Intake = Intervention 1: Control; no Caffeine Intake

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ketonemia Following Caffeine Intake = Intervention 2: Caffeine Low Dose (2.5 mg/kg of BW)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ketonemia Following Caffeine Intake = Intervention 3: Caffeine High Dose (5 mg/kg of BW)

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

Pr. Stephen Cunnane

Université de Sherbrooke

Phone: 819-780-2220

Email: stephen.cunnane@usherbrooke.ca

Results disclosure agreements

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