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Completed

NCT Number: NCT02694601

Ketone Production With Acute Caffeine Intake

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

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Key information

Conditions

Healthy Adults Acid-Base Imbalance Acidosis Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Sherbrooke, Quebec, J1H4C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Dietary Supplement

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

Other names: CTL

Caffeine low dose

Dietary 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 dose

Dietary Supplement

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

Primary outcomes

  1. Plasma Acetoacetate Concentrations

    Time frame: 4 hours

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

  2. Plasma Beta-hydroxybutyrate Concentrations

    Time frame: 4 hours

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

Secondary outcomes

  1. Plasma Glucose Concentrations

    Time frame: 4 hours

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

  2. Plasma Cholesterol Concentrations

    Time frame: 4 hours

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

  3. Plasma Triglyceride Concentrations

    Time frame: 4 hours

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

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

Stimulate the Ketogenesis by Using a Caffeine Supplement

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 29, 2016
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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