NCT05975489

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

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

October 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
Last Updated

August 8, 2023

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

July 27, 2023

Last Update Submit

August 3, 2023

Conditions

Genetic PredispositionCaffeineFat Burn

Outcome Measures

Primary Outcomes (3)

  • Genotype frequency of CYP1A2 polymorphism

    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

    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

    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 Outcomes (4)

  • FATmax

    2-months

  • MFO

    2-months

  • RPE

    2-months

  • FAT and CHO oxidation

    2-months

Study Arms (3)

Caffeine 3mg/kg intake

EXPERIMENTAL

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

Caffeine 6mg/kg intake

EXPERIMENTAL

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

Placebo intake

PLACEBO COMPARATOR

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

Interventions

Acute caffeine supplementationDIETARY_SUPPLEMENT

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

Caffeine 3mg/kg intakeCaffeine 6mg/kg intakePlacebo intake

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • To have VO2max values below 40 ml/kg/min To be sedentary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Related Publications (1)

  • Varillas-Delgado D, Coso JD, Munoz A, Aguilar-Navarro M, Gutierrez-Hellin J. Influence of the CYP1A2 c.-163 A > C polymorphism in the effect of caffeine on fat oxidation during exercise: a pilot randomized, double-blind, crossover, placebo-controlled trial. Eur J Nutr. 2024 Oct;63(7):2697-2708. doi: 10.1007/s00394-024-03454-3. Epub 2024 Jul 15.

    PMID: 39007997DERIVED

MeSH Terms

Conditions

Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Disease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Varillas Delgado

    Universidad Francisco de Vitoria, crta Pozuelo-Majadahonda km 1.800 PC 28223, Madrid, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2023

First Posted

August 4, 2023

Study Start

October 1, 2020

Primary Completion

February 10, 2021

Study Completion

April 1, 2022

Last Updated

August 8, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)