NCT02694601

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

June 15, 2018

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

February 9, 2016

Results QC Date

September 12, 2017

Last Update Submit

July 18, 2023

Conditions

Healthy Adults

Keywords

KetonesGlucoseCaffeine

Outcome Measures

Primary Outcomes (2)

  • Plasma Acetoacetate Concentrations

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

    4 hours

  • Plasma Beta-hydroxybutyrate Concentrations

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

    4 hours

Secondary Outcomes (3)

  • Plasma Glucose Concentrations

    4 hours

  • Plasma Cholesterol Concentrations

    4 hours

  • Plasma Triglyceride Concentrations

    4 hours

Study Arms (1)

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)

Dietary Supplement: ControlDietary Supplement: Caffeine low doseDietary Supplement: Caffeine high dose

Interventions

ControlDIETARY_SUPPLEMENT

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

Also known as: CTL
Ketonemia following caffeine intake
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.

Ketonemia following caffeine intake
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.

Ketonemia following caffeine intake

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults
  • years old and over

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)

Sherbrooke, Quebec, J1H4C4, Canada

Location

MeSH Terms

Conditions

Ketosis

Interventions

Caffeine

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Pr. Stephen Cunnane
Organization
Université de Sherbrooke
stephen.cunnane@usherbrooke.ca
819-780-2220

Study Officials

  • Stephen Cunnane, PhD

    Research Centre on Aging - CSSS-IUGS - CIUSSS de l'Estrie - CHUS

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 29, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

June 1, 2015

Last Updated

July 27, 2023

Results First Posted

June 15, 2018

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)