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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Spain
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Dietary supplement: Acute caffeine supplementation
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.
Dietary supplement: Acute caffeine supplementation
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.
Dietary supplement: Acute caffeine supplementation
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Francisco de Vitoria

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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