NCT04320446

Brief Summary

Maximal fat oxidation during exercise (MFO) and the intensity of exercise that elicits MFO (Fatmax) has been recognized as potential determinants of endurance performance. The purpose of this study was to determine the possible interaction between the effects of diurnal variation (morning vs. afternoon) and caffeine ingestion on MFO, Fatmax and VO2 max in endurance-trained men. Specifically, the investigators sought to elucidate whether the stimulant actions of caffeine could reverse the decrements of MFO and Fatmax observed in the morning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

March 19, 2020

Last Update Submit

March 24, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • MFO

    Maximal fat oxidation during exercise

    Through study completion, an average of 1 month

Secondary Outcomes (2)

  • FATmax

    Through study completion, an average of 1 month

  • VO2max

    Through study completion, an average of 1 month

Study Arms (2)

Caffeine

EXPERIMENTAL

A dose of 3 mg/kg of caffeine (i.e. a vegetable extraction from green coffee beans, Harrison Sport Nutrition®, Spain) was ingested before the beginning of each test.

Behavioral: Test in the morningBehavioral: Test in the afternoon

Placebo

PLACEBO COMPARATOR

A dose of 3 mg/kg of placebo (i.e. 100% purity microcrystalline cellulose, Acofarma, Spain) was ingested before the beginning of each test.

Behavioral: Test in the morningBehavioral: Test in the afternoon

Interventions

The exercise test was performed between 8 a.m and 11 a.m

Also known as: MFO-morning, Fatmax-morning, and VO2max-morning
CaffeinePlacebo

The exercise test was performed between 5 p.m. and 8 p.m.a

Also known as: (MFO-afternoon, Fatmax-afternoon, and VO2max-afternoon
CaffeinePlacebo

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having a body mass index (BMI) ranged from 18.5 to 28 kg/m2
  • not suffering any specific disease which can be aggravated by physical exercise
  • having previous experience in endurance training (i.e. self-reporting at least 2 years of cycling or running training including more than 3 training sessions/week).

You may not qualify if:

  • Being smoker
  • Taking medication or drugs
  • Any non-controlled medical condition which could influence results or could be worsened by the participation in the study
  • Are deemed unsuitable by the investigator for any other reason, that prevent data collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Mixto Universitario Deporte Salud

Granada, 18016, Spain

Location

Related Publications (1)

  • Ramirez-Maldonado M, Jurado-Fasoli L, Del Coso J, R Ruiz J, Amaro-Gahete FJ. Caffeine increases maximal fat oxidation during a graded exercise test: is there a diurnal variation? J Int Soc Sports Nutr. 2021 Jan 7;18(1):5. doi: 10.1186/s12970-020-00400-6.

Study Officials

  • Jonatan Ruiz Ruiz, Dr.

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 25, 2020

Study Start

June 1, 2019

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations