Healthy AdultsNCT02694601
Ketone Production With Acute Caffeine Intake
A study testing Caffeine low dose and Caffeine high dose in people with Healthy Adults, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Evaluate the effect of a caffeine supplement on the stimulation of lipolysis and the production of ketones in healthy adults (N=10). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Caffeine low dose and Caffeine high dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- 18 years old and over
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
Sherbrooke, Quebec, J1H4C4
About this study
Official title: Stimulate the Ketogenesis by Using a Caffeine Supplement
Evaluate the effect of a caffeine supplement on the stimulation of lipolysis and the production of ketones in healthy adults (N=10).
Read the 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.
- Conditions
- Healthy Adults
- Being tested
- Control, Caffeine low dose, Caffeine high dose
- Keywords
- Ketones, Glucose, Caffeine
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDietary supplement
Also called CTL
4-hour visit with no caffeine is given during a standardize breakfast follow by repeated blood sampling.
Caffeine low doseDietary supplement
4-hour visit with a dose of 2.5 mg/kg of caffeine is given during a standardize breakfast follow by repeated blood sampling.
Caffeine high doseDietary supplement
4-hour visit with a dose of 5 mg/kg of caffeine is given during a standardize breakfast follow by repeated blood sampling.
| Study group | Role | What they receive |
|---|---|---|
| Ketonemia following caffeine intake | Experimental | 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 (5.0 mg/kg of MW) Receives: Dietary Supplement: Control; Dietary Supplement: Caffeine low dose; Dietary Supplement: Caffeine high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Acetoacetate Concentrations
Plasma acetoacetate (µmol/L) measured over a 4 hour period.
Measured: 4 hours
Plasma Beta-hydroxybutyrate Concentrations
Plasma beta-hydroxybutyrate (µmol/L) measured over a 4 hour period.
Measured: 4 hours
Secondary outcomes (3)
Plasma Glucose Concentrations
Plasma glucose (mmol/L) measured over a 4 hour period.
Measured: 4 hours
Plasma Cholesterol Concentrations
Plasma cholesterol (mmol/L) measured over a 4 hour period.
Measured: 4 hours
Plasma Triglyceride Concentrations
Plasma triglycerides (mmol/L) measured over a 4 hour period.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Cunnane, PhD, Principal investigator, Research Centre on Aging - CSSS-IUGS - CIUSSS de l'Estrie - CHUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694601
- Sponsor's protocol ID
- 2014-441
- Status last verified
- Jul 2023
- First submitted
- 9 Feb 2016
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulate the Ketogenesis by Using a Caffeine Supplement
- ClinicalTrials.gov ID
- NCT02694601
- Acronym / sponsor ID
- 2014-441
- Conditions
- Healthy Adults
- Keywords
- Ketones, Glucose, Caffeine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Posted 15 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketonemia following caffeine intake | Experimental | Dietary Supplement: Control, Dietary Supplement: Caffeine low dose, Dietary Supplement: Caffeine high doseParticipants 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 (5.0 mg/kg of MW) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults
- 18 years old and over
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlAlso: CTL4-hour visit with no caffeine is given during a standardize breakfast follow by repeated blood sampling. | Dietary supplement | Ketonemia following caffeine intake |
| Caffeine low dose4-hour visit with a dose of 2.5 mg/kg of caffeine is given during a standardize breakfast follow by repeated blood sampling. | Dietary supplement | Ketonemia following caffeine intake |
| Caffeine high dose4-hour visit with a dose of 5 mg/kg of caffeine is given during a standardize breakfast follow by repeated blood sampling. | Dietary supplement | Ketonemia following caffeine intake |
Primary outcome
Plasma Acetoacetate Concentrations
Time frame: 4 hours
Plasma acetoacetate (µmol/L) measured over a 4 hour period.
Plasma Beta-hydroxybutyrate Concentrations
Time frame: 4 hours
Plasma beta-hydroxybutyrate (µmol/L) measured over a 4 hour period.
3 secondary outcomes
Plasma Glucose Concentrations
Time frame: 4 hours
Plasma Cholesterol Concentrations
Time frame: 4 hours
Plasma Triglyceride Concentrations
Time frame: 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Cunnane, PhD principal investigator
Research Centre on Aging - CSSS-IUGS - CIUSSS de l'Estrie - CHUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine low dose and Caffeine high dose in people with Healthy Adults, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Acetoacetate Concentrations (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.