- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05975489
Genetics in the Effect of Caffeine on Fat Oxidation
August 3, 2023 updated by: Universidad Francisco de Vitoria
Influence of the Genetic Polymorphisms in the Effect of Caffeine on Fat Oxidation During Exercise
Genetic polymorphism on the effect of oral caffeine intake on fat oxidation during exercise has been studied in active and healthy population performing an incremental test on a cycle ergometer with 3-min stages at workloads from 30 to 70% of maximal oxygen uptake (VO2max).
Participants performed this test after the ingestion of a) placebo; b) 3 mg/kg of caffeine; c) 6 mg/kg of caffeine.
Fat oxidation rate during exercise was measured by indirect calorimetry.
The influence of the CYP1A2 c.-163A>C, GSTP c.313A>G and PGC1a polymorphisms was evaluated to determine the effects on fat oxidation during exercise
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Caffeine is a natural stimulant with well-recognized sports performance benefits.
Aside its performance-enhancing effect, caffeine has the potential of increasing fat utilization during aerobic exercise at submaximal intensities, lowering-down the contribution of carbohydrate as a fuel.
This property of caffeine may provoke a glycogen-sparing effect in the skeletal muscle and liver for exercise situations where carbohydrate availability may be a challenge.
Additionally, the capacity of caffeine to enhance fat utilization during exercise could be of interest for improving health outcomes as it may increase the rate of change in body composition in exercise programs.
Genetic factors like CYP1A2 c.-163A>C, GSTP c.313A>G and PGC1a c.1444G>A and C>T polymorphisms could be associated with the capacity for fat oxidation during exercise.
To date, it is unknown if genetics increases fat oxidation and MFO in the same proportion during morning and evening exercise trials in women.
For this reason, the aim of the present study was to evaluate the influence of the tCYP1A2, GSTP and PGC1a polymorphisms on the effect of caffeine on fat oxidation and MFO in active and healthy population.
The authors hypothesised that genetics would increase fat oxidation and MFO during exercise and this effect would be of similar magnitude at several caffeine doses.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Madrid
-
Pozuelo De Alarcón, Madrid, Spain, 28223
- Universidad Francisco de Vitoria
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
To be non-smokers. To have low caffeine intake (i.e., < 50 mg of caffeine per day in the previous 2 months) To show no previous history of cardiopulmonary diseases or having suffered musculoskeletal injuries in the previous 6 months.
Exclusion Criteria:
To have VO2max values below 40 ml/kg/min To be sedentary
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Caffeine 3mg/kg intake
A dose of 3 mg/kg of caffeine (Bulk Powders, Essex, United Kingdom) was ingested before the beginning of each test.
|
To evaluate the influence of the time of the day (i.e., morning vs evening) on the effect of caffeine on maximal fat oxidation in women
|
|
Experimental: Caffeine 6mg/kg intake
A dose of 6 mg/kg of caffeine (Bulk Powders, Essex, United Kingdom) was ingested before the beginning of each test.
|
To evaluate the influence of the time of the day (i.e., morning vs evening) on the effect of caffeine on maximal fat oxidation in women
|
|
Placebo Comparator: Placebo intake
A dose of 3 mg/kg of placebo (Cellulose, Guinama, Valencia, Spain) was ingested before the beginning of each test.
|
To evaluate the influence of the time of the day (i.e., morning vs evening) on the effect of caffeine on maximal fat oxidation in women
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Genotype frequency of CYP1A2 polymorphism
Time Frame: Baseline
|
Samples shall be obtained by swabbing and scraping of the buccal mucosa by the participant.
The c.-163A>C (rs762551) polymorphism will be used.
|
Baseline
|
|
Genotype frequency of GSTP polymorphism
Time Frame: Baseline
|
Samples shall be obtained by swabbing and scraping of the buccal mucosa by the participant.
The c.1444G>A (rs8192678) and C>T (rs17650401) polymorphisms will be used.
|
Baseline
|
|
Genotype frequency of PGC1a polymorphisms
Time Frame: Baseline
|
Samples shall be obtained by swabbing and scraping of the buccal mucosa by the participant.
The c.313A>G (rs1695) polymorphism will be used.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MFO
Time Frame: 2-months
|
Maximal fat oxidation during exercise
|
2-months
|
|
FATmax
Time Frame: 2-months
|
The intensity of exercise that elicits MFO
|
2-months
|
|
RPE
Time Frame: 2-months
|
Rate of percevied exertion during exercise
|
2-months
|
|
FAT and CHO oxidation
Time Frame: 2-months
|
Fat and carbohydrates oxidation
|
2-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Varillas Delgado, Universidad Francisco de Vitoria, crta Pozuelo-Majadahonda km 1.800 PC 28223, Madrid, Spain
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Actual)
February 10, 2021
Study Completion (Actual)
April 1, 2022
Study Registration Dates
First Submitted
July 27, 2023
First Submitted That Met QC Criteria
July 27, 2023
First Posted (Actual)
August 4, 2023
Study Record Updates
Last Update Posted (Actual)
August 8, 2023
Last Update Submitted That Met QC Criteria
August 3, 2023
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Disease Susceptibility
- Genetic Predisposition to Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Purinergic Antagonists
- Purinergic Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Central Nervous System Stimulants
- Caffeine
Other Study ID Numbers
- UFV_genetic_caffeine
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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