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Ketone Production With Acute Caffeine Intake

Stimulate the Ketogenesis by Using a Caffeine Supplement

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02694601
Enrollment
10
Registered
2016-02-29
Start date
2014-01-31
Completion date
2015-06-30
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults

Keywords

Ketones, Glucose, Caffeine

Brief summary

Evaluate the effect of a caffeine supplement on the stimulation of lipolysis and the production of ketones in healthy adults (N=10).

Detailed description

The aim of the study is to evaluate the effect of a caffeine supplement on the stimulation of lipolysis and the production of ketones in healthy adults (N=10). Two different doses of caffeine (2.5 mg/kg of BW and 5 mg/kg of BW) are compared. All the 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.

Interventions

DIETARY_SUPPLEMENTControl

4-hour visit with no caffeine is given during a standardize breakfast follow by repeated blood sampling.

DIETARY_SUPPLEMENTCaffeine low dose

4-hour visit with a dose of 2.5 mg/kg of caffeine is given during a standardize breakfast follow by repeated blood sampling.

DIETARY_SUPPLEMENTCaffeine high dose

4-hour visit with a dose of 5 mg/kg of caffeine is given during a standardize breakfast follow by repeated blood sampling.

Sponsors

Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy adults * 18 years old and over

Exclusion criteria

* Drinking more than 300 mg of caffeine per day * Diabetes or prediabetes * Abnormal liver and kidney function * Uncontrolled dyslipidemia, blood pressure * Use of drugs known to influence the metabolism of lipids and carbohydrates (steroid, beta-blockers, diuretics, insulin sensitizer, etc.) * Severe inflammation or infection * Pregnancy * Smoking

Design outcomes

Primary

MeasureTime frameDescription
Plasma Acetoacetate Concentrations4 hoursPlasma acetoacetate (µmol/L) measured over a 4 hour period.
Plasma Beta-hydroxybutyrate Concentrations4 hoursPlasma beta-hydroxybutyrate (µmol/L) measured over a 4 hour period.

Secondary

MeasureTime frameDescription
Plasma Glucose Concentrations4 hoursPlasma glucose (mmol/L) measured over a 4 hour period.
Plasma Cholesterol Concentrations4 hoursPlasma cholesterol (mmol/L) measured over a 4 hour period.
Plasma Triglyceride Concentrations4 hoursPlasma triglycerides (mmol/L) measured over a 4 hour period.

Countries

Canada

Participant flow

Participants by arm

ArmCount
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)
10
Total10

Baseline characteristics

CharacteristicKetonemia Following Caffeine Intake
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
Age, Continuous33 years
STANDARD_DEVIATION 19
Region of Enrollment
Canada
10 Participants
Sex: Female, Male
Female
8 Participants
Sex: Female, Male
Male
2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 100 / 100 / 10
serious
Total, serious adverse events
0 / 100 / 100 / 10

Outcome results

Primary

Plasma Acetoacetate Concentrations

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

Time frame: 4 hours

ArmMeasureGroupValue (MEAN)Dispersion
Ketonemia Following Caffeine IntakePlasma Acetoacetate ConcentrationsCTL26.06 µmol/LStandard Error 3.71
Ketonemia Following Caffeine IntakePlasma Acetoacetate ConcentrationsCaffeine low dose30.99 µmol/LStandard Error 5.97
Ketonemia Following Caffeine IntakePlasma Acetoacetate ConcentrationsCaffeine high dose32.10 µmol/LStandard Error 8.4
Primary

Plasma Beta-hydroxybutyrate Concentrations

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

Time frame: 4 hours

ArmMeasureGroupValue (MEAN)Dispersion
Ketonemia Following Caffeine IntakePlasma Beta-hydroxybutyrate ConcentrationsCTL92.69 µmol/LStandard Error 12.41
Ketonemia Following Caffeine IntakePlasma Beta-hydroxybutyrate ConcentrationsCaffeine low dose127.57 µmol/LStandard Error 16.98
Ketonemia Following Caffeine IntakePlasma Beta-hydroxybutyrate ConcentrationsCaffeine high dose144.99 µmol/LStandard Error 16.77
Secondary

Plasma Cholesterol Concentrations

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

Time frame: 4 hours

ArmMeasureGroupValue (MEAN)Dispersion
Ketonemia Following Caffeine IntakePlasma Cholesterol ConcentrationsCaffeine low dose4.76 mmol/LStandard Error 0.35
Ketonemia Following Caffeine IntakePlasma Cholesterol ConcentrationsCaffeine high dose4.81 mmol/LStandard Error 0.34
Ketonemia Following Caffeine IntakePlasma Cholesterol ConcentrationsCTL4.26 mmol/LStandard Error 0.47
Secondary

Plasma Glucose Concentrations

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

Time frame: 4 hours

ArmMeasureGroupValue (MEAN)Dispersion
Ketonemia Following Caffeine IntakePlasma Glucose ConcentrationsCTL4.95 mmol/LStandard Error 0.35
Ketonemia Following Caffeine IntakePlasma Glucose ConcentrationsCaffeine low dose4.96 mmol/LStandard Error 0.29
Ketonemia Following Caffeine IntakePlasma Glucose ConcentrationsCaffeine high dose4.98 mmol/LStandard Error 0.25
Secondary

Plasma Triglyceride Concentrations

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

Time frame: 4 hours

ArmMeasureGroupValue (MEAN)Dispersion
Ketonemia Following Caffeine IntakePlasma Triglyceride ConcentrationsCTL0.90 mmol/LStandard Error 0.15
Ketonemia Following Caffeine IntakePlasma Triglyceride ConcentrationsCaffeine low dosee0.92 mmol/LStandard Error 0.15
Ketonemia Following Caffeine IntakePlasma Triglyceride ConcentrationsCaffeine high dosee0.97 mmol/LStandard Error 0.14

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026