- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02694601
Ketone Production With Acute Caffeine Intake
Stimulate the Ketogenesis by Using a Caffeine Supplement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1H4C4
- Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 (5.0 mg/kg of MW) |
4-hour visit with no caffeine is given during a standardize breakfast follow by repeated blood sampling.
Other Names:
4-hour visit with a dose of 2.5 mg/kg of caffeine is given during a standardize breakfast follow by repeated blood sampling.
4-hour visit with a dose of 5 mg/kg of caffeine is given during a standardize breakfast follow by repeated blood sampling.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Acetoacetate Concentrations
Time Frame: 4 hours
|
Plasma acetoacetate (µmol/L) measured over a 4 hour period.
|
4 hours
|
Plasma Beta-hydroxybutyrate Concentrations
Time Frame: 4 hours
|
Plasma beta-hydroxybutyrate (µmol/L) measured over a 4 hour period.
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Glucose Concentrations
Time Frame: 4 hours
|
Plasma glucose (mmol/L) measured over a 4 hour period.
|
4 hours
|
Plasma Cholesterol Concentrations
Time Frame: 4 hours
|
Plasma cholesterol (mmol/L) measured over a 4 hour period.
|
4 hours
|
Plasma Triglyceride Concentrations
Time Frame: 4 hours
|
Plasma triglycerides (mmol/L) measured over a 4 hour period.
|
4 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephen Cunnane, PhD, Research Centre on Aging - CSSS-IUGS - CIUSSS de l'Estrie - CHUS
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-441
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Adults
-
KU LeuvenCompletedHealthy Older Adults | Ill Older AdultsBelgium
-
Samsung Medical CenterTerminatedHealthy Aging | Healthy AdultsKorea, Republic of
-
Lumos Labs, Inc.Not yet recruitingHealthy AdultsUnited States
-
Shirley Ryan AbilityLabNot yet recruiting
-
National Institute of Allergy and Infectious Diseases...RecruitingHealthy AdultsUnited States
-
Arizona State UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingHealthy AdultsUnited States
-
Marian NeuhouserDuke University; University of Washington; University of Nebraska; United States...Recruiting
-
Mirati Therapeutics Inc.CompletedHealthy AdultsUnited States
-
Ohio State UniversityActive, not recruitingHealthy AdultsUnited States
-
Ohio State UniversityActive, not recruitingHealthy AdultsUnited States
Clinical Trials on Control
-
Claudia M. WittCompleted
-
University of California, San FranciscoWithdrawn
-
The George InstituteChanghai Hospital; University of CalgaryNot yet recruiting
-
Universidad Nacional de Educación a DistanciaMinisterio de Economía y Competitividad, SpainUnknownChronic Pain | FibromyalgiaSpain
-
University of California, Los AngelesThe National Council on Aging; City of Los Angeles Department of Aging; Los Angeles...Completed
-
Queen's University, BelfastPublic Health Agency, Health and Social Care Research and Development; Tiny...Completed
-
National Taiwan University HospitalEnrolling by invitationCognitive Function | Atrial Fibrillation, PersistentTaiwan
-
Takeshi MorimotoUniversity of the RyukyusActive, not recruitingCoronary Artery Disease | Hypertension | Type 2 Diabetes | DyslipidemiaJapan
-
Johnson & Johnson Vision Care, Inc.TerminatedRefractive Error CorrectionUnited States
-
Vanderbilt University Medical CenterCompleted